Job Summary Job Description JOB SUMMARY Responsible for leading the management of master validation program and compliance maintenance to assure global regulatory validations requirements in Medline manufacturing facilities, contract manufactured products, and software systems. Support Corporate Process Validation program and related activities, analyzes problems related to quality manufacturing, risk management, global regulatory information, and to provide systems and technical support resolution MAJOR RESPONSIBILITIES - Support senior management in development of validations process, master validation plan, and strategies that support the success of the business. - Identifies, leads, and drives opportunities to improve validation systems. - Manage the Compliance Master Validations team responsible for oversight of the validation of software, facility utilities, equipment processes and cleaning for cGMP products such as pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820, and other applicable regulatory requirements. - Develop and Manage Medline’s supplier master validation plans and validation documentation meets all applicable requirements, including those for CE marked devices for process, cleaning, and software validations. - Audit Suppliers to assure compliance to Medline’s validation requirements. - Lead validation process and optimize the current processes to reduce costs and increase capacity. - Review and approve Medline validation protocols and reports. - Stay current with AAMI/ISO standards and review changes to make sure validations are in compliance with new domestic and global requirements. - Review and revise Corporate Validation procedures and processes to make sure they are in line with current practices and regulatory requirements. - Execute responsibilities as CRB team member to assure adequacy of corrective actions including identify risk and compliance opportunities. - Assist in Risk Management activities including those related to validations and CRB activities. - Provide global support for FDA and ISO inspections related to validations and validation strategy. - Provide training to personnel globally on a variety of topics related to validations and process controls. - Management responsibilities include: - Typically oversees professional employees/teams OR typically manages non-professional employees through Supervisors in manufacturing, distribution or office environments. - Day-to-day operations of a group of employees. - May have limited budgetary responsibility and usually contributes to budgetary impact; - Interpret and execute policies for departments/projects and develops. - Recommend and implement new policies or modifications to existing policies. - Provide general guidelines and parameters for staff functioning. - Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies. MINIMUM JOB REQUIREMENTS Education Bachelor’s degree in engineering, chemistry, biology, or related sciences. Work Experience - At least 4 years of experience with medical device or pharma, QA and/or Quality Management Systems including validations. - Experience authorizing medical device process validation protocols and reports Knowledge/Skills/Abilities Detail-oriented with excellent oral and written communication skills. - Ability to listen and process all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions. - Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives and determining when escalation of issues is necessary. Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines. - Position requires travel up to 20% of the time for business purposes (within state, out of state and/or internationally). PREFERREDJOB REQUIREMENTS Work Experience - At least 5 years of experience with medical device or pharma, QA and/or Quality Management Systems including validations. - At least 1 year of experiencing with managing people within an FDA regulated environment. - Experience developing validation strategies and programs. Experience auditing compliance to FDA regulated Medical Device or Pharmaceuticals requirements. - Experience with regulated Medical Device or Pharmaceutical risk management practices. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $134,000.00 - $201,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Do you like working with different project teams in a fast-paced environment? Are you interested in joining an organization focused on making a positive impact? If so, we’d like to talk with you about growing with us. EnSafe is seeking a full-time Environmental Compliance Specialist to join our Charleston, SC, or Jacksonville, FL office. This is an excellent opportunity to join and grow EnSafe, getting involved in a variety of projects for diverse clients worldwide. This position is offered as a remote role. As an Environmental Compliance Specialist, you will lead our junior environmental compliance staff and work closely with EnSafe's senior-level compliance teams to manage our clients and projects in the SE and across the United States. This will involve client management, proposal development, project management, coordination, and implementation of comprehensive project work. EnSafe's environmental compliance professionals evaluate industrial facilities' compliance with regulations governing air, water, and waste, assist clients with obtaining and complying with environmental permits, and help facilities identify and meet other environmental obligations. EnSafe is committed to providing pragmatic, cost-effective strategies to maintain compliance, minimize liability, and improve environmental performance. As an Environmental Compliance Specialist, you will work on a wide range of projects in an environment that fosters creativity, collaboration at all levels, a culture of support, and professional growth. EnSafe emphasizes empowering staff to practice our profession passionately and without limitations.  DUTIES/RESPONSIBILITIES In this role, you will: - Apply local, state, and federal environmental regulations to deliver defensible compliance solutions for commercial, industrial, municipal, and state government clients while supporting client development and market growth. - Independently develop, prepare, and submit environmental compliance documents such as Spill Prevention Control & Countermeasure Plans, Storm Water Pollution Prevention Plans, annual EPCRA Tier II and TRI reports, Annual Waste Summaries, Industrial Wastewater Discharge Permit Applications, and Semi-Annual Compliance reports in accordance with local, state, and federal requirements, serving as the technical owner and primary author of deliverables. - Perform hands-on environmental compliance audits for EnSafe clients that identify regulatory non-conformances and associated corrective actions. - Serve as the technical lead to ensure corrective and preventive actions are implemented to address non-conformities at client sites. - Develop and implement multimedia environmental compliance programs across wastewater, stormwater, hazardous waste, and EPCRA (Tier II, Form R/TRI 312 and 313 reporting). - Provide project management for environmental compliance and permitting engagements, including proposal development, technical execution, project coordination, and project billing. - Support and help lead the environmental compliance service line in the southeast including mentoring and supervising junior compliance staff with an emphasis on technical consulting development. - Periodic overnight travel to client locations in Texas as well as throughout the U.S. to support consulting engagements and compliance activities. - After successful integration into EnSafe and project management, move into client management and development. SKILLS/EXPERIENCE Minimum Skills and Requirements: - Bachelor of Science in engineering, environmental science, or related field. - 10+ years of relevant Environmental Compliance experience with consulting experience. - A Professional Engineering license, Certified Hazardous Materials Manager, or other environmental certifications are preferred. - Seasoned technical writer; able to produce technically complete permit applications, contingency plans, compliance audit reports, annual compliance reports, and technical responses to regulatory agencies based on technical data and engineering analyses. - Strong consulting, relationship-building, and critical thinking skills are required. - Project management experience, including developing scopes of work, cost proposals, and schedules, and managing multiple project teams simultaneously. Why Join EnSafe? - Employee-Owned Advantage EnSafe is 100% employee-owned, with an ESOP (Employee Stock Ownership Plan) since 1997. That means when EnSafe succeeds, you succeed too, turning company growth directly into shared rewards. - Commitment to Growth and Wellness The company supports personalized career development, mentorship, and employee wellness initiatives such as health tracking tools. - Purpose‑Driven Work EnSafe’s mission focuses on impactful environmental, health, and safety consulting—making a real difference in communities and is backed by its long-standing technical credibility.  - Safety as a Value, Not Just a Service Safety is deeply embedded in our culture, prioritizing employee well-being in addition to helping clients maintain compliance. We stress that “safety is part of everything we do.” - A Culture of Freedom & Ownership At EnSafe, our career philosophy is built on freedom. The freedom to take initiative, achieve your goals, and shape your own career path Employees are encouraged to pursue growth in a flexible, entrepreneurial environment.  - Challenging, Creative Work Workdays at EnSafe are anything but ordinary, fast-paced, dynamic, and filled with opportunities to tackle projects in environmental consulting, health & safety, engineering, and technology. Every day calls for creativity, innovation, and agile problem-solving. About EnSafe EnSafe began as a two-person firm in 1980, navigating complex regulatory compliance issues on behalf of our clients. We nurture our people with growth and development opportunities. We build enduring, trustful relationships with each of our clients, with a focus on high ethical and safety standards. We build this reputation by attracting high-quality people and retaining them for the long term. At EnSafe, we are dedicated to fostering a diverse and authentic workplace, so if you’re excited about this role but your experience doesn’t align perfectly with every qualification in the job description, we encourage you to apply anyway. You may be just the right candidate for this or other roles at our company. EnSafe is committed to being an EEO employer and all qualified candidates will receive consideration without regard to race, color, religion, national origin, citizenship, age (except for bona fide occupational qualifications), sex, disability, sexual orientation, gender identity, marital status, military or veteran status, any other status protected by federal, state, or local law, or association with a person on the basis on one or more of the foregoing. Check us out on the web at www.ensafe.com Applicant Privacy Notice | AI use in Hiring

Role Description The Staff Quality Engineer is responsible for providing quality engineering direction to projects, such as: - Risk management - Design concepts - Design specifications - Design for quality and manufacturing requirements - Process/technology development - Design and process validation - Measurement systems analysis - Equipment and software validation - Project planning - Associated documentation This position will play an active role in developing the quality management system and ensuring QMS compliance adherence. Qualifications - Minimum 5 years relevant experience in the medical device industry. - Experience in Quality System requirements, such as: - Design Control - Risk Management - Quality - Production Process Controls - Supplier Controls - Corrective and Preventive Action - Non-Conformance - Complaint Management - Post Market Surveillance - Bachelor's Degree in Life Sciences, Engineering, or equivalent is preferred. - Biomedical or Quality Auditor certification desired. Requirements - Develop, establish, and maintain QA processes, procedures, and controls ensuring that performance and quality of products conform to established standards and regulations. - Work with R&D, Manufacturing Engineering, Regulatory, and Clinical team to develop and execute Quality Engineering activities to meet project milestones. - Provide guidance and oversee the documentation process (Design History File, Device History Records and Device Master Records). - Participate in designing and drafting plans/protocols for testing of complex medical device products with the Quality and R&D team. - Lead Risk Management efforts in accordance with ISO 14971 and Design Control efforts in accordance with ISO 13485 and 21CFR 820. - Participate on Corrective and Preventive Action teams in response to concerns identified through complaints, nonconforming materials or other trending activities. - Qualify new suppliers, maintain the Approved Supplier List (ASL), and manage the Supplier Corrective Action Request (SCAR) program. - Participate in Quality Assurance audits from 3rd party agencies, ensure timely and effective resolution of issues identified. - Maintain quality system in compliance with all applicable regulatory standards (FDA QMSR, ISO 13485, MDR requirements) and other relevant requirements throughout the facility. - Identify and implement changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system using: quality policy, quality objectives, audit results, analysis of data, etc. - Other duties as assigned. Company Description

Join the Texas Health and Human Services Commission (HHSC) and be part of a team committed to creating a positive impact in the lives of fellow Texans. At HHSC, your contributions matter, and we support you at each stage of your life and work journey. Our comprehensive benefits package includes 100% paid employee health insurance for full-time eligible employees, a defined benefit pension plan, generous time off benefits, numerous opportunities for career advancement and more. Explore more details on the Benefits of Working at HHS webpage. Functional Title: Program Compliance Coordinator Job Title: Program Specialist VI Agency: Health & Human Services Comm Department: Settlement Agreement Complianc Posting Number: 15209 Closing Date: 04/06/2026 Posting Audience: Internal and External Occupational Category: Personal Care and Services Salary Range: $5,098.66 - $8,304.83 Pay Frequency: Monthly Salary Group: TEXAS-B-23 Shift: Day Additional Shift: Telework: Eligible for Telework Travel: Up to 35% Regular/Temporary: Regular Full Time/Part Time: Full time FLSA Exempt/Non-Exempt: Exempt Facility Location: Job Location City: AUSTIN Job Location Address: 909 W 45TH ST #634 BLDG 4 Other Locations: MOS Codes: 16GX,60C0,611X,612X,63G0,641X,712X,86M0,8U000,OS,OSS,PERS,YN,YNS Brief Job Description: Come work in an environment where we truly value and respect those we serve and believe in the mission that all people can achieve a higher level of wellness and independence. The state supported living centers serve people with intellectual and developmental disabilities who are medically fragile or who have behavioral problems. The centers provide campus-based direct services and supports at 13 centers located throughout the state. Learn About Our State Supported Living Centers If you are looking for a place to work where you can establish a career that is filled with purpose, this is the job for you! The Program Compliance Coordinator (PCC) reports to the Quality Assurance Manager and is a member of the Quality Improvement team at the State Supported Living Center (SSLC) State Office. This position can be based anywhere in Texas and must routinely report to their headquarters location. This position requires significant travel to SSLCs (35% of work schedule). The PCC is assigned to 6 or 7 SSLCs and serves as a Quality Assurance subject matter expert. Performs highly advanced (senior-level) consultative services and technical assistance work in the areas of quality assurance and improvement. The PCC works closely with the SSLC State Office team and SSLC staff to monitor and report progress towards compliance with Intermediate Care Facility for Individuals with Intellectual Disability (ICF-IID) Conditions of Participation and quality assurance and quality improvement (QA/QI) processes and initiatives. As part of the QA and QI oversight process, conducts remote and on-site review of documents, on-site observations and interviews, and prepares narrative reports. Assists with the development of improvement plans and other QA/QI activities as needed. Tracks recommendations when plans of improvement are initiated to assist Centers with action step implementation and ensure recommendations are completed and have supporting evidence. Provides updates on SSLC progress in response to findings and action plans. Travels to assigned SSLCs to monitor and provide technical assistance to Center staff on minimum requirements and best practices. Works under minimal supervision, with considerable latitude for the use of initiative and independent judgment. Essential Job Functions (EJFs): Attends work on a regular basis and may be required to work a specific shift schedule or, at times, even a rotating schedule, extended shift and/or overtime in accordance with agency leave policy and performs other duties as assigned. May serve in an on-call status on a rotating schedule as required to meet operational needs of the SSLCs. Extensive travel (35%) is required. For assigned SSLCs, provides technical support, on-site or virtually, during quality assurance-oriented meetings. Meetings include Quality Assurance/Quality Improvement Council (QAQI) meetings, monthly/quarterly department lead meetings, State Office monthly QA meeting with assigned Centers, corrective action plan (CAP) team meetings, and plan of improvement (POI) meetings. Elevates concerns to the Quality Assurance Manager. Conducts at least one on-site visit annually, or more as needed, to provide on-site monitoring, verify/validate the completion of QA action plans and implementation of directives. While on-site, evaluates programs, procedures, and/or processes for effectiveness through the use of designated monitoring tools. Analyzes data and documentation and provides recommendations for improvement or identification of best practices. Participates in internal State Office meetings to discuss findings, observations, provide updates when needed, and with the help of other State Office staff, identify issues requiring SSLC Director notification, and assists in developing actions to address compliance gaps or performance concerns. Provides technical assistance to other State Office staff and the Center, as needed. After each on-site visit, prepares a report of findings within assigned time frames. Provides updates on status to Center administration and State Office both verbally and in writing. Submits the report to the Quality Assurance Manager for approval and distributes to State Office and the Center. Works with the Center after the visit to coordinate action plans and improvements. Addresses comments and questions about findings from Center and/or State Office staff. Makes recommendations to improve QA and QI processes when needed. In between on-site visits, regularly reviews QAQI reports, data inventory, and improvement plans for assigned Centers to provide feedback and work with Center staff to clarify and edit them. Provides oversight and verification of Center QA processes such as submitting required documents, completing quality audits, and conducting data validation. When needed, coordinates the Center, State Office discipline coordinators, and QA staff when progress is not made or concerns are identified. When a plan of improvement (POI) is required for an assigned Center, the PCC compiles the POI by collecting data from QA and action items from subject matter experts and serves as liaison between the Center and State Office throughout the POI process. Conducts on-site observations at a determined interval to verify POI action steps are complete. Attends all POI meetings and communicates concerns to SSLC leadership. Collaborates with other State Office staff to promote facility compliance with Intermediate Care Facility for Individuals with Intellectual Disability (ICF-IID) Conditions of Participation and system-wide policies and procedures. Analyzes the implementation of and variation within processes across SSLCs to develop action plans for improving processes or initiating new ones. Provides consultation and technical assistance on quality assurance and improvement processes to other State Office staff. Other potential collaborative activities include developing program policies, procedures, standards, and manuals, developing and implementing new monitoring tools, identifying the need for new programs, and providing training and guidance to staff in the development and integration of new methods and procedures. As needed, conducts on-site visits to assigned Centers to assist with review or implementation of ad hoc Center initiatives. Duties for ad-hoc visits could include compiling data and preparing a report within assigned time frames after the on-site review. Provides updates on status to Center administration and State Office both verbally and in writing. Works with the Center after the review to coordinate action plans and improvements. Develops recommendations to improve QA/QI processes when needed. Other duties as assigned include but are not limited to actively participating and/or serving in a supporting role to meet the agency’s obligations for disaster response and/or recovery or Continuity of Operations (COOP) activation. Such participation may require an alternate shift pattern assignment and/or location. Knowledge, Skills and Abilities (KSAs): Basic knowledge of local, state, and federal laws and standards related to the program area to include Intermediate Care Facilities/Individuals with Intellectual Disabilities (ICF/IID), Texas Administrative Code (TAC), and HHSC policies and procedures related to State Supported Living Centers, or ability to gain that knowledge. Knowledge of security procedures for handling, protection, and distribution of confidential data. Working knowledge and understanding of electronic health records. Knowledge of statistical analysis processes; and of program planning and implementation. Skill in data validation. Skill in using monitoring tools to evaluate performance. Ability to gather, assemble, correlate, and analyze facts. Ability to devise solutions to problems. Ability to prepare technical reports, to communicate effectively, to train, lead and coordinate the work of others. Ability to collect, interpret, organize, verify, and disseminate significant amounts of information with attention to detail and accuracy. Ability to provide direction and guidance to others Ability to travel extensively (35% of the time) Registrations, Licensure Requirements or Certifications: None Initial Screening Criteria: Bachelor’s degree from an accredited college or university with at least one year of ICF-IID experience OR Associate’s degree with three years of ICF-IID experience. Experience writing reports. Experience conducting on-site monitoring, observations or program assessments. Experience evaluating compliance with administrative and programmatic requirements, policies, and guidelines is preferred. Additional Information: Applicants must pass a fingerprint criminal background check, pre-employment drug screen, and registry checks including the Client Abuse/Neglect Reporting System (CANRS), Nurse Aide, Medication Aide and Employee Misconduct and HHS List of Excluded Individuals/ Entities (LEIE). Males between the ages of 18 – 25 must be registered with the Selective Service. All State Supported Living Center Employees are subject to Random Drug Testing. Flexibility in work hours may be required for this position. The position may be required to work overtime and/or extended hours. Must be willing to work weekends and holidays. All applicants must be at least 18 years of age to be considered for employment at a state-operated facility. Review our Tips for Success when applying for jobs at DFPS, DSHS and HHSC. Active Duty, Military, Reservists, Guardsmen, and Veterans: Military occupation(s) that relate to the initial selection criteria and registration or licensure requirements for this position may include, but not limited to those listed in this posting. All active-duty military, reservists, guardsmen, and veterans are encouraged to apply if qualified to fill this position. For more information please see the Texas State Auditor’s Job Descriptions, Military Crosswalk and Military Crosswalk Guide at Texas State Auditor's Office - Job Descriptions. ADA Accommodations: In compliance with the Americans with Disabilities Act (ADA), HHSC and DSHS agencies will provide reasonable accommodation during the hiring and selection process for qualified individuals with a disability. If you need assistance completing the on-line application, contact the HHS Employee Service Center at 1-888-894-4747. If you are contacted for an interview and need accommodation to participate in the interview process, please notify the person scheduling the interview. Pre-Employment Checks and Work Eligibility: Depending on the program area and position requirements, applicants selected for hire may be required to pass background and other due diligence checks. HHSC uses E-Verify. You must bring your I-9 documentation with you on your first day of work. Download the I-9 Form Telework Disclaimer: This position may be eligible for telework. Please note, all HHS positions are subject to state and agency telework policies in addition to the discretion of the direct supervisor and business needs.