Role Description The Senior Global Supplier Quality Professional II is responsible for executing global supplier quality strategies to ensure that externally sourced materials, components, and services consistently meet quality, regulatory, and business requirements. This role acts as a key interface between internal cross-functional teams (Quality, R&D, Operations, Procurement) and suppliers worldwide, driving supplier performance, compliance, and continuous improvement. The position operates within a regulated environment and supports global quality systems aligned to applicable standards (e.g., ISO 13485, FDA 21 CFR Part 820), ensuring end-to-end supplier lifecycle management—from qualification through ongoing monitoring and development. Key Responsibilities - Execution of global supplier quality strategies, policies, and procedures across regions and business units - Ensure alignment of supplier quality processes with Quality Management System (QMS) requirements and regulatory standards - Partner with Global Supply Chain and Procurement to establish supplier segmentation, risk classification, and oversight models - Assist in supplier selection, qualification, onboarding, and inclusion in Approved Supplier Lists (ASL) - Conduct and/or lead supplier audits (initial, surveillance, for-cause) to assess compliance with quality and regulatory standards - Assist in maintaining supplier quality agreements, specifications, and performance expectations - Monitor key supplier performance metrics (e.g., defect rates, on-time delivery, cost of poor quality) - Identify performance trends and drive continuous improvement initiatives with suppliers - Execute the supplier development programs to improve process capability, reduce variability, and enhance product quality - Represent Global Supplier Quality in root cause investigations and resolution of supplier quality issues using structured problem-solving methodologies (e.g., 8D, DMAIC) - Drive Supplier Corrective and Preventive Actions (SCAR/CAPA) and verify effectiveness of implemented actions - Execute non-conformances, deviations, and escalation processes across global supply base - Ensure supplier controls meet applicable regulatory requirements (e.g., ISO 13485, FDA, GMP) - Support internal and external audits, inspections, and regulatory submissions related to supplier quality - Maintain audit readiness through proper documentation, traceability, and quality records - Partner with R&D, Engineering, and Operations on new product development and supplier integration activities - Provide supplier quality input into design controls, risk management, and validation activities - Work cross functionally with internal stakeholders and global suppliers - Mentor junior supplier quality professionals and provide technical guidance across the organization - Assist in cross-functional and cross-regional initiatives to drive harmonization and best practices - Influence decision-making through data-driven insights and supplier performance analytics Qualifications - Bachelor’s degree in life sciences, engineering, or related field required; advanced degree preferred. - 8+ years of progressive quality experience in Supplier Quality, Quality Engineering, or Quality Systems in a regulated industry - Demonstrated experience working with global suppliers and cross-regional teams - Strong knowledge of Quality Management Systems (QMS) and supplier controls - Experience with regulatory standards such as ISO 13485, ISO 9001, FDA 21 CFR Part 820, and/or GMP requirements - Proficiency in quality tools and methodologies (e.g., FMEA, SPC, process validation, statistical analysis) - Experience managing supplier audits, CAPA systems, and change control processes - Advanced problem-solving and root cause analysis capabilities - Strong project management skills with ability to manage multiple initiatives globally - Excellent communication and stakeholder management skills across technical and non-technical audiences - Ability to influence without authority and drive accountability across a global supply base - High level of analytical capability with experience interpreting supplier performance data - Willingness to travel globally up to 30%. Preferred Qualifications - ASQ Certification (CQE, CQA, CSQP) or equivalent - Six Sigma Green/Black Belt - Experience in medical device, pharmaceutical, or other highly regulated industries - Experience supporting new product introduction (NPI) and supplier validation activities Benefits - Medical, Dental, & Vision - Health Savings Accounts - Flexible Spending Accounts - Disability Benefits - Life Insurance - Voluntary Benefits - Paid Absences - 401k Benefits Equal Opportunity Employer Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

QUALITY COORDINATOR Location: Roseburg, Oregon, USA Work Arrangement: Hybrid (must be able to travel to the Roseburg office at 3031 NE Stephens St., Roseburg, OR 97470) Job Type: Full-time (Exempt) Department: Quality Job Description: About Umpqua Health At Umpqua Health, we’re more than a healthcare organization—we’re a community-driven Coordinated Care Organization (CCO) dedicated to improving the health and well-being of individuals and families throughout Douglas County, Oregon. We provide integrated, whole-person care through primary care, specialty care, behavioral health services, and care coordination. Our collaborative approach ensures members receive high-quality, personalized care while supporting a stronger, healthier community. Roles & Responsibilities Quality Improvement Committee (QIC) & Quality Deliverable Coordination - Collaborate with Senior Director, Quality and Data Management to support the Quality Improvement Committee (QIC). - Attend the monthly QIC. - Track deadlines, deliverables, and follow-up actions using the QIC meeting matrix. - Draft and distribute agendas, notes, and summary communications. - Communicate updates and help resolve routine issues. - Support policy management related to QIC and subcommittee approval and oversight. - Coordinate UHA’s Performance Improvement Projects (PIPs). - Coordinate UHA’s Quality Assessment & Process Improvement (QAPI) Program as well as coordinates the annual update of the trilogy documents and gathers regular updates throughout the year from subject matter experts. - Attend the monthly Quality Metrics Subcommittee. Present as needed. - Attend the monthly Metrics Technical Advisory Group (TAG) meeting. - Attend the afternoon sessions of the Quality Health Outcomes Committee (QHOC). Actively participate and share PIP, QAPI, and QI related updates with manager and team. Policy & Procedure Support - Track the annual review schedule for all Quality Policies and Procedures (P&Ps) and Standard Operating Procedures (SOPs) including those for the Quality Department and under QIC and Subcommittee oversight. - Monitor submission timelines in PolicyTech and remind subject matter experts when their documents need review. - Help subject matter experts navigate PolicyTech to ensure successful submission and approval. - Add reviewed P&Ps/SOPs to QIC agendas, prepare any necessary summaries, and present changes for approval. - Maintain clear documentation of status, timelines, and approval progress. Marketing & Quality Initiatives Coordination - Act as the primary point of contact between Marketing and Quality for all quality-related communication, resources, and initiatives. - Maintain and update Quality resources on the organization’s website to ensure content is accurate, accessible, and up to date. - Lead and facilitate the monthly Quality–Marketing Department meeting: develop agenda, guide discussion, track follow-up actions, and elevate cross-departmental opportunities. - Manage all external partner resource orders in coordination with Marketing to ensure timely delivery of patient and provider materials. - Oversee and administer the Healthy Start and Prevention First Gift Card Programs, including process oversight, documentation, and coordination with internal and external stakeholders. - Gather Quality-related content from the department (monthly for provider newsletters and quarterly for member newsletters) and represent the Quality team at the monthly Provider & Member Newsletter Workgroup, ensuring Quality content is accurately included and identifying opportunities for additional contributions. Ad Hoc & Team Coverage - Own and manage the IET notification process, ensuring accuracy and timeliness of communications. - Learn the DHS notification process for HIT & Metrics Program Manager backup. - Support end-of-year reporting with data entry. - Supporting implementation and coordination of quality improvement and population health initiatives - Providing cross-functional support and backup coverage to improve operational continuity CHALLENGES - Working with a variety of personalities, maintaining a consistent and fair communication style - Satisfying the needs of a fast-paced and challenging company. - Balancing regulatory compliance, member-centered care, and operational efficiency in a complex and evolving CCO environment. MINIMUM QUALIFICATIONS - Bachelor's degree in healthcare administration, Public Health, Nursing, or a related field required - Minimum of three (3) years of experience in healthcare quality management, quality improvement, healthcare operations, or related fields. - Strong analytical, organizational, and problem-solving skills with experience utilizing data management and reporting tools. - Excellent written, verbal, and interpersonal communication skills with the ability to collaborate effectively across departments and stakeholders. - Ability to manage multiple priorities, work independently, and meet deadlines in a fast-paced environment. - Knowledge of CLAS principles and a demonstrated commitment to diversity, equity, inclusion, and health equity initiatives. - Certification in Healthcare Quality (e.g., CPHQ) or related certification preferred. - Valid driver’s license, access to a reliable vehicle, and ability to maintain required automobile insurance. - Must not be suspended, excluded, or debarred from participation in federal healthcare programs (e.g., Medicare/Medicaid). PREFERRED QUALIFICATIONS - Experience with healthcare quality improvement methodologies and project management principles - Experience working with CCO quality metrics, performance measures, and/or NCQA accreditation standards. - Experience working in a clinical setting and/or directly with healthcare providers. - Certification in Healthcare Quality (e.g., CPHQ) or related certification. - Bilingual translation or translation capabilities a plus SCHEDULE Monday through Friday - 8:00 am - 5:00 pm; standard business hours with flexibility to meet service timelines. SALARY Wage Band: $ 80,470- $94,550 BENEFITS - Salary is dependent on skills, experience, and education - Generous benefits package including vacation PTO, sick leave, federal holidays, and birthday leave - Medical, dental, and vision insurance - 401(k) with company match (fully vested immediately) - Company-sponsored life insurance and additional benefits - Fitness reimbursement program - Tuition reimbursement and more Why Umpqua Health? We are committed to advancing health equity by collaborating across communities, addressing systemic barriers, and ensuring fair access to care and resources. At Umpqua Health, every team member plays a vital role in making a meaningful impact, empowering healthier lives and strengthening the communities we serve. Inclusive Culture We foster a respectful, inclusive environment where employees feel valued, supported, and empowered. Growth & Development We support ongoing learning through mentorship, clear career pathways, and professional development opportunities. Work/Life Balance We promote flexibility and well-being so employees can thrive both professionally and personally. Equal Opportunity Umpqua Health is an equal opportunity employer that embraces individuals from all backgrounds. We prohibit discrimination and harassment of any kind, ensuring that all employment decisions are based on qualifications, merit, and the needs of the business. Our dedication to fairness and equality extends to all aspects of employment, including hiring, training, promotion, and compensation, without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other protected category under federal, state, or local law.

• Execute functional, integration, system, and user acceptance testing activities • Create, maintain, and execute test cases, test scenarios, and test scripts • Identify, document, and track defects through resolution • Collaborate with business users, developers, and project stakeholders to validate system functionality • Participate in reviews and ensure test coverage aligns with business needs • Support validation of system enhancements, defect fixes, and production releases • Utilize testing and defect management tools such as JIRA and Selenium

• Leverage technology to automate and optimize validations, profile data, implement business rules, visualize results, and work with data stewards in all applications/lines of business to address any data quality issues. • Provide first-level subject matter expertise between the business and IT to ensure the data requirements are accurate and specific, as well as ensure the output meets the acceptance criteria. • Assist in validations, build adequate controls using point-to-point testing, and use source to target mapping to ensure high quality results for all data implementations and projects. • Help troubleshoot, trace, and identify root causes of quality issues which involves dissecting Stored Procedures, STTM documents and source data. • Assist in the monitoring of controls and aid in remediation as required.