Sustaining Engineering Manager
About The Position
The Sustaining Engineering Manager is responsible for leading the Quality Engineering teams to resolve problems and execute improvements to ensure products meet specifications and applicable regulations with appropriate documentation. This role owns the end-to-end response to quality events including customer complaints, nonconformances, and CAPAs, driving rapid containment, thorough root cause analysis, and effective corrective actions. Acting as a central point of integration across operations, quality systems, and customer interfaces, the manager ensures seamless issue resolution while maintaining audit readiness and adherence to applicable ISO 13485 and FDA 21 CFR Part 820 requirements. Additionally, this role establishes and scales processes for change management, continuous improvement, and risk mitigation, while serving as the escalation point for complex technical and quality challenges impacting production products and overall business performance.
Requirements
- Bachelor’s degree in engineering or related technical discipline (Mechanical, Biomedical, Manufacturing preferred).
- 7+ years of experience in medical device or regulated manufacturing, including direct ownership of post-market quality systems.
- Minimum 2+ years of leadership experience managing engineering or quality teams.
- Strong experience with complaint handling, nonconformance (DMR) systems, and CAPA execution in an eQMS environment
- Working knowledge of ISO 13485, FDA 21 CFR Part 820, and risk management frameworks (ISO 14971).
- Excellent communication skills, written and verbal with ability to consistently comply with documentation requirements.
- Demonstrates initiative and independence: Proactively seeks new opportunities and exhibits self-confidence, is action oriented and makes things happen, despite apparent roadblocks.
- Strong leadership presence with the ability to drive accountability across cross-functional teams.
- Advanced problem-solving capability with expertise in root cause analysis and data-driven decision making.
- Operationally focused with a bias for execution, speed, and disciplined follow-through.
- Effective communicator capable of influencing stakeholders at all levels, including customers and executive leadership.
- Highly organized with the ability to manage multiple high-priority issues simultaneously in a fast-paced environment.
- Ability to lift up to 30lbs as needed
- Can speak, understand and write English.
- Able to identify examples of personal leadership and technical contributions related to successful projects.
- Able to provide examples of “can do” positive attitude and successful outcomes for challenging projects with tight timelines.
Responsibilities
- Lead, mentor, and scale the Quality Engineering team responsible for containment, investigation, and resolution of quality events.
- Oversee timely execution of complaint handling, nonconformance management (including DMRs), and CAPA processes, ensuring robust root cause analysis and effectiveness.
- Govern released product change management, including technical review and approval of ECOs and manufacturing method assessments for product or process changes.
- Ensure effective coordination of containment activities (e.g., sort, rework, inspection) and alignment with production and quality systems workflows.
- Provide leadership and subject matter expertise during internal audits, customer audits, and regulatory inspections.
- Drive cross-functional communication and escalation management across manufacturing, engineering, supply chain, and commercial teams.
- Deliver measurable improvements in complaint response times, CAPA closure effectiveness, and nonconformance reduction.
- Ensure sustaining engineering activities are compliant with applicable ISO 13485:2016, FDA 21 CFR Part 820, and internal QMS requirements.
- Maintain a constant state of audit readiness with no major findings attributable to sustaining processes.
- Ensure timely and effective containment and resolution of quality issues to minimize customer and operational impact.
- Drive reduction in cost of poor quality (COPQ) through systemic corrective actions and continuous improvement initiatives.
- Maintain accurate technical documentation and design history files
- Support audits and regulatory inspections
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
11-50 employees
