A search is underway for a Senior Quality Manager to lead manufacturing quality within a highly regulated production environment. This leader will have broad ownership of day-to-day quality operations, oversee Quality Engineering and QC functions, and drive the systems, compliance, and continuous improvement initiatives that support reliable manufacturing performance.
Key Responsibilities
- Lead manufacturing quality operations, including in-process and final inspection, product acceptance, and release.
- Direct and develop Quality Engineering and QC teams, establishing clear accountability and a strong culture of quality.
- Own NCR/MRB, CAPA, root-cause investigation, and corrective-action processes through effective resolution and closure.
- Drive quality, yield, efficiency, and risk-reduction initiatives using Lean, Six Sigma, and data-driven methodologies.
- Ensure ongoing compliance with ISO 13485, FDA QMSR, and applicable regulatory requirements; support internal, FDA, and notified-body audits.
- Partner closely with Manufacturing, Engineering, Supply Chain, and Operations on quality risks, process improvements, supplier performance, and new product or process introductions.
- Provide senior leadership with clear reporting on quality performance, emerging risks, trends, and improvement priorities.
Ideal Candidate Profile
- 8+ years of progressive manufacturing quality experience, with required experience in medical devices and exposure to other highly regulated industries such as aerospace, defense, or IVD considered relevant.
- Demonstrated leadership experience managing Quality Engineers, QC professionals, and/or front-line quality supervisors.
- Deep hands-on expertise in manufacturing quality, NCR/MRB, CAPA, root-cause analysis, risk management, and shop-floor quality execution.
- Strong working knowledge of ISO 13485, FDA quality requirements, audit readiness, and regulated manufacturing environments.
- Engineering degree preferred, ideally Mechanical, Electrical, or a related discipline; equivalent depth of experience may be considered.
- Willingness to maintain an on-site leadership presence and travel approximately 5–10% as required.
Key Areas of Impact
- Manufacturing Quality Leadership, establishing disciplined, data-driven quality execution across production operations.
- Quality Systems & Compliance, strengthening regulatory readiness and quality-system effectiveness within a highly regulated environment.
- Continuous Improvement, improving yield, efficiency, process capability, and risk performance through structured problem solving.
- Team Leadership, building and developing a high-performing Quality organization capable of supporting both current operations and future growth.
Interested in this search?
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