• Develop and maintain automated tests for new feature functionality within the sprint. • Build and expand automated regression test suites to ensure stability of existing features. • Define, estimate, prioritize, and coordinate testing activities within the scrum team. • Contribute to and enhance internally built test automation frameworks. • Design scalable and maintainable test strategies for UI, API, and integration testing. • Identify, log, and track defects, ensuring clear and actionable bug reports. • Collaborate closely with developers, product managers, and DevOps to ensure shift-left testing practices. • Analyze failures across distributed systems, including logs, traces, and service interactions. • Ensure quality across end-to-end POS workflows, including offline/online scenarios and edge cases. • Support and improve CI/CD pipelines, ensuring automated tests are integrated into release workflows. • Mentor and guide QA engineers, fostering a culture of automation and quality ownership.

• Develop and execute comprehensive test plans, test cases, and test scripts • Perform functional, integration, regression, and performance testing • Validate data migration from legacy systems • Collaborate with developers and stakeholders to design test strategies • Identify, document, and track defects using tools like Jira • Participate in Agile ceremonies for quality assurance insights • Support user acceptance testing (UAT) and validate training materials • Create and maintain QA documentation for gate reviews

Role Description As a Sr. Engineer, Design Quality, you will be responsible for ensuring that product design, development, and lifecycle changes meet all applicable quality and regulatory requirements across Getinge’s Infection Control Consumables portfolio. This includes FDA Class I and II medical devices, EU MDR Class I devices, and selected non-regulated products. You will serve as a core quality leader within cross-functional teams, providing design assurance oversight and driving compliance across the full product lifecycle. This includes ownership of design control execution, risk management activities, and change governance within the Arena PLM system. You will act as a subject matter expert (SME) in design quality, influencing decision-making, ensuring inspection readiness, and driving adherence to internal procedures and external standards including FDA 21 CFR 820/QMSR, ISO 13485, ISO 14971, and EU MDR. Qualifications - Demonstrated leadership, problem-solving, decision-making, influencing, facilitation, and communication skills. - Deep knowledge of applicable quality and regulatory standards, including FDA 21 CFR 820/QMSR, ISO 13485, ISO 14971, and EU MDR 2017/745. - Strong expertise in design control, risk management, and product lifecycle management. - Proven ability to lead cross-functional team discussions and influence decision-making without direct authority. - Advanced analytical and problem-solving skills, including root cause analysis and risk-based decision making. - Strong technical writing and documentation review skills with high attention to detail. - Experience with statistical methods, sampling plans, and data analysis. - Experience supporting design changes across the product lifecycle and working within PLM systems (Arena preferred). - Ability to work effectively in a fast-paced, cross-functional, and highly regulated environment. - Excellent interpersonal skills, with the ability to develop collaborative relationships across teams and functions. Requirements - Bachelor’s degree in science, engineering, or other technical areas; or equivalent job experience required. Advanced degree preferred. - 5+ years of relevant experience in the medical device industry; and have several years of experience in Design Quality, Quality Engineering, or a related role within the medical device industry. - Applied knowledge of ISO 13485:2016, ISO 14971:2019, 21 CFR 820 QSMR, and EU Medical Device Regulation 2017/745 (MDR). - Working knowledge of international standards and regulations applicable to medical devices and combination products. - Familiarity with Geometric Dimensioning and Tolerancing (GD&T) standards and principles. - Experience supporting design changes across the product lifecycle, hands-on experience with a PLM system (Arena preferred). - Ability to apply practical and technical problem solving to quality system and product improvements. - Excellent interpersonal skills, including ability to work effectively cross-culturally and cross-functionally. - Proven ability to effectively lead cross-functional team meetings. - Capable of developing matrix relationships with key colleagues in other functional areas and divisions. - Champions high quality deliverables, innovation, and appropriate risk-based decision making. - Ability to understand the sensitivity within Getinge’s environment. - Excellent project management and interpersonal skills. - Adaptable to changes in work environment. - Ability to work in a fast-paced environment. - The position is remote, with 25% travel as needed. Benefits - Health, Dental, and Vision insurance benefits - 401k plan with company match - Paid Time Off - Wellness initiative & Health Assistance Resources - Life Insurance - Short and Long Term Disability Benefits - Health and Dependent Care Flexible Spending Accounts - Commuter Benefits - Parental and Caregiver Leave - Tuition Reimbursement

Role Description The Senior Manager, Quality Assurance GCP will support the Good Clinical Practice (GCP) Quality Assurance (QA) function, and performance of GCP QA operations. The role also supports QA oversight for non-clinical laboratories, including Good Laboratory Practice (GLP). This individual will manage and oversee assigned audits, support regulatory inspections, and support the quality oversight and compliance program at Crinetics Pharmaceuticals. Essential Job Functions and Responsibilities - Manage, oversee, conduct, and report on assigned GCP and GLP qualification and routine vendor audits and others as required (internal system/process, TMF, clinical site, data, and clinical documents). - Generate and maintain annual audit programs and manage schedules. - Maintain trackers and trend audit findings / CAPAs / resolution processes across programs to identify systemic issues and drive preventive actions. - Manage and perform vendor risk assessments. - Maintain and archive QA electronic vendor files and audit documentation. - Reconcile master vendor tracker and vendor records. - Manage GCP and GLP quality agreements with vendors. - Attend vendor governance and oversight meetings. - Provide GCP guidance and feedback for research and development activities; participate in clinical study team meetings and discuss clinical study-related compliance topics. - Identify and escalate significant compliance risks to senior management. - Provide guidance and support to Trial Master File activities. - Review clinical study documents (protocols, ICFs, study plans, IB, CSR, etc.) of moderate complexity and provide feedback. - Foster a collaborative environment that supports GCP compliance and continuous improvement; identify and mitigate potential compliance risks. - Review deviations, quality issues, and CAPAs; perform investigations and root cause analysis. - Develop and maintain professional cross-functional and cross-departmental relationships. - Interpret and apply global regulations of moderate complexity. - Identify compliance gaps and develop corrections or improvements. - Support inspection-readiness activities and regulatory inspections. - Develop, modify, and execute SOPs, Work Instructions, Policies, and/or Job Aids. - Develop training materials with minimal support; administer GCP training. - Manage multiple projects simultaneously / multi-tasking. - Support other quality driven activities and initiatives. - Other duties as assigned. Qualifications - Minimum with a Bachelor’s degree and at least 12 Years of experience in a QA function within the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered). - Ability to interpret FDA, EU, ICH, and other global GCP regulations. - Previous experience conducting GCP QA audits (vendor, investigator site, internal). - Provide guidance to auditors and junior level staff; manage and supervise auditor activities and assign tasks and goals. - Knowledge working with QMS in vendor management, SOPs, internal audits, deviations, and CAPAs. - Demonstrates sound analytical and problem-solving abilities to resolve complex issues that involve numerous components. - Excellent collaboration, interpersonal, verbal, and written communication skills. - Outstanding organizational, prioritization skills, with attention to detail. - Good presentation skills to both internal and external audiences. - Able to work on issues where analysis of situations or data requires conceptual thinking and in-depth knowledge. - Able to facilitate moderate to complex investigations. - Has knowledge and experience using a risk-based approach. Requirements - Experience in GLP and GVP, a plus. - Regulatory inspection experience highly desired. - Auditor certification and/or RQAP-GCP certification, a plus. Travel You may be required to travel for up to 35% of your time. Equal Opportunity Employer Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Salary Range The salary range for this position is: $133,000 - $166,000. In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.