Quality Engineering Manager (Medtech)

TL;DR

Quality Engineering Manager (Medtech): Leading the quality engineering team to ensure medical devices and processes meet regulatory standards with an accent on compliance, risk management, and continuous improvement. Focus on overseeing CAPA, executing V&V protocols, and implementing statistical analysis for process capability.

Location: Onsite in Grand Rapids, Michigan, USA

Salary: $150,000 – $211,200 per year

Company

hirify.global is a global leader in medical technology, specializing in the development of innovative healthcare solutions and medical devices.

What you will do

• Lead and mentor the quality engineering team, providing guidance, training, and performance feedback.
• Oversee quality systems to ensure compliance with GMP, 21 CFR Part 820, ISO 13485, and EU MDR.
• Manage the investigation and resolution of product quality issues, non-conformances, and CAPA.
• Develop and apply robust risk management strategies using PHA and PFMEA.
• Direct V&V protocols (IQ, OQ, PQ) and utilize Minitab and Power BI for statistical analysis and data-driven decisions.
• Support manufacturing operations for finished medical devices within the Cardiac Surgery Business Unit.

Requirements

• Bachelor's degree in Biomedical, Mechanical, or Industrial Engineering with 5+ years of experience, or a Master's degree with 3+ years of experience in the medical device industry.
• Must be based in or able to work onsite in Grand Rapids, Michigan (Relocation assistance not available).
• Proven expertise with GMP, 21 CFR Part 820 QSR, ISO 13485, and EU MDR.
• Experience with Risk Assessments (PHA, PFMEA) and managing Non-Conformances and CAPA.
• Proficiency in DMAIC, RCA, DOE, and statistical analysis tools (Cpk/Ppk, ANOVA, Gage R&R).
• Experience with Minitab, Power BI, and V&V protocols (IQ, OQ, PQ).

Culture & Benefits

• Comprehensive health, dental, and vision insurance, including HSA and Healthcare FSA.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and an Employee Stock Purchase Plan.
• Tuition assistance/reimbursement and global well-being programs.
• Life insurance and long-term disability leave.