Quality Engineering Manager

General Summary

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.

• 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
• Indicates an essential function of the role

Minimum education and experience:

• Bachelor’s 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
• Previous manufacturing engineering, process development, or NPI 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

• 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. Power
  
  BI or Tableau), statistical analysis, and design of experimentation

• General office, laboratory, and cleanroom environments
• Business travel from 0% - 10%
• Requires some lifting and moving of up to 25 pounds
• Must be able to move between buildings and floors
• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day
• Must be able to read, prepare emails, and produce documents and spreadsheets
• Must be able to move within the office and access file cabinets or…