The Senior Manager, Quality Engineering is a people leadership and manufacturing role responsible for providing quality and compliance oversight. This leader will manage and develop a team of Quality Engineers while partnering closely with Operations, Manufacturing Engineering, Facilities, Maintenance, and Supply Chain to ensure manufacturing activities are performed safely, effectively, and in compliance with applicable quality system requirements.
The position will oversee quality and compliance activities supporting the plant's major production areas, including THV manufacturing, TMTT manufacturing, advanced catheters, and metals. The successful candidate will strengthen NCR and CAPA execution, improve investigation quality, monitor operational quality metrics, and establish effective communication and continuity.
How You'll Make an Impact:- Lead, coach, and develop a team of Quality Engineers supporting manufacturing operations, establishing clear expectations, accountability, and individual development plans.
- Provide quality and compliance oversight for manufacturing activities, ensuring operations are performed in accordance with approved procedures, quality system requirements, and applicable regulatory standards.
- Oversee the initiation, investigation, review, approval, and timely closure of nonconformance reports, including evaluating investigation quality, root cause determination, corrective actions, and product or process risk.
- Own and provide leadership for CAPAs, including investigation strategy, root cause analysis, action planning, implementation, effectiveness verification, and sustainable closure.
- Lead the deployment, implementation, and continuous improvement of quality management systems and manufacturing quality processes aligned with ISO 13485 and 21 CFR Part 820.
- Review and approve test method validations, measurement system analyses, and manufacturing process validations, including IQ, OQ, and PQ documentation.
- Monitor quality metrics, trends, investigation performance, and quality data reviews; identify emerging risks and provide actionable recommendations to Operations and Quality leadership.
- Support internal and external audits by ensuring operations remain inspection-ready, responding to auditor questions, and leading or supporting actions resulting from audit observations.
- Partner with Operations, Manufacturing Engineering, Manufacturing, Facilities, Maintenance, and Supply Chain to resolve quality issues, maintain compliant production, and strengthen operational controls.
- Establish effective shift-to-shift communication and escalation processes to ensure timely transfer of quality, production, and compliance information.
- Provide quality leadership for supplier-related issues, as applicable, including investigation support, corrective actions, and supplier performance concerns.
- Promote a culture of quality, accountability, continuous improvement, and proactive risk management.
- Develop and implement quality processes that improve product compliance, operational performance, and customer satisfaction.
- Other incidental duties as assigned.
What You'll Need (Required):- Bachelor's degree with relevant Quality Engineering, Quality Management, or Manufacturing Quality experience within a highly regulated environment; or equivalent experience based on Edwards' criteria.
- Demonstrated people leadership experience managing and developing engineers or other technical quality professionals.
- Experience deploying, implementing, or sustaining quality management systems within a regulated manufacturing environment, including working knowledge of ISO 13485 and 21 CFR Part 820 requirements.
- Strong experience leading CAPAs, nonconformance investigations, and structured root cause analysis, including evaluation of investigation quality and effectiveness.
What Else We Look For (Preferred):- Engineering or Scientific degree
- Medical device manufacturing experience
- Experience providing quality oversight for manufacturing or production operations, including partnering directly with Operations and Engineering to resolve compliance and product quality issues.
- Demonstrated ability to interpret quality data, monitor operational quality metrics, recognize adverse trends, and escalate significant risks.
- Experience with microbiology principles or microbiological controls in a regulated manufacturing environment.
- Experience supporting cleanroom qualification, environmental controls, or manufacturing operations performed within controlled environments.
- Supplier quality or supplier management experience, including supplier investigations and corrective actions.
- Experience reviewing or approving test method validations and measurement system analysis studies.
- Experience reviewing or approving manufacturing process validations, including IQ/OQ/PQ.
- Experience supporting internal, external, or regulatory audits.
- Experience leading quality activities across multiple manufacturing technologies, product lines, or production areas.
- Knowledge of statistical methods, process capability, measurement systems, risk management, and continuous improvement tools.
- Demonstrated success strengthening team capability, improving organizational effectiveness, and leading change within a manufacturing quality organization.
- Strong written and verbal communication skills, with the ability to influence decisions and communicate effectively across technical, operational, and leadership audiences.
