Quality Engineering Manager
About The Position
In this role, you will lead a team of Quality Engineers supporting manufacturing operations and production lines for a portfolio of medical devices. You will be accountable for manufacturing quality performance, inspection strategy, yield improvement, and sustaining process control, from early commercial ramp through product maturity and site transfer. Embedded within Technical Operations, this role partners closely with Manufacturing Engineering, Production, and Industrial Engineering to build quality into manufacturing processes from the start. From a quality-first perspective, you will ensure processes are capable, controlled, and appropriately de-risked through robust process controls, inspection strategies, and data-driven monitoring. Your work will directly influence product yield, productivity, and operational stability by preventing defects, detecting issues early, and ensuring consistent, compliant manufacturing performance.
Requirements
- Bachelorâs degree in Engineering (Biomedical, Mechanical, Materials, Chemical, or related discipline preferred)
- 5+ years of experience in Quality Engineering, or Manufacturing Engineering within the medical device industry
- 1+ years of leadership experience required; people management experience preferred
- Working knowledge of FDA QSR and ISO 13485 in a manufacturing environment
- Prior people leadership experience or demonstrated readiness to manage and develop engineers
- Strong data analysis, problem-solving, and decision-making skills
Nice To Haves
- Product Quality Engineering support for catheterization delivery systems and/or nitinol-based devices
- Experience supporting high-volume manufacturing and early commercial yield ramp
- Strong background in inspection systems, destructive testing, and statistical sampling methods
- Versatility, flexibility, and willingness to work within a dynamic environment
- Practical application of Lean and Six Sigma in manufacturing or quality environments
- Experience partnering closely with Production, Industrial Engineering, and Equipment Engineering teams
- CQE certification or training
- Experience with data systems (e.g. PowerBI or Tableau), statistical analysis, and design of experimentation
Responsibilities
- Lead Quality Engineering support for assigned product portfolios and production lines
- Serve as the primary quality partner to Production, Manufacturing Engineering, and Industrial Engineering
- Own manufacturing quality performance, including yield, scrap, productivity, and throughput-related quality losses
- Own and advance inspection strategies, including in-process and final inspection, destructive testing, sampling plans, and acceptance/reject criteria
- Drive continuous improvement of inspection systems, test methods, process monitoring, and digital quality tools
- Apply Lean and Six Sigma methodologies to improve yield, reduce waste, and enhance process capability
- Own execution of quality system activities within Operations, including NCRs, MRB, CAPAs, control chart investigations, and effectiveness verification
- Champion process-based risk management, including pFMEAs and defining CTQs
- Review and approve equipment-related quality activities, including equipment qualifications (IQ/OQ), equipment-related ECOs, non-standard maintenance activities, and equipment software validation, in partnership with Manufacturing Engineering
- Hire, develop, and manage Quality Engineers, including workload and FTE planning to support production priorities
Benefits
- A collaborative teamwork environment where learning is constant, and performance is rewarded.
- The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
- A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
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What This Job Offers
Job Type
Full-time
Career Level
Manager
