Sr. Quality Engineer
Core
Develop and maintain quality plans, procedures, and specifications to ensure compliance with regulatory requirements and industry standards for medical device products.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Medical device products ensuring quality, safety, and effectiveness
Domain
Medical Technology / Healthcare
Required skills
Design controls, Risk management (ISO 14971), CAPA processes, FDA QSR (21 CFR Part 820), ISO 13485, Statistical analysis, Quality tools (Minitab, SPC, FMEA), Root cause analysis, Supplier quality management, Continuous improvement (Lean, Six Sigma)
Preferred skills
ASQ certifications (CQE, CSSBB), Class II or III device experience
Technologies
Minitab, SPC, FMEA
Responsibilities
Develop and maintain quality plans and procedures; Support product development through design control activities; Investigate nonconformances and drive CAPA; Plan and execute internal and external audits; Partner with suppliers for qualification and monitoring; Analyze quality metrics and trends; Lead continuous improvement initiatives; Deliver training to cross-functional teams; Collaborate with R&D, Manufacturing, and Regulatory Affairs; Support regulatory submissions.
Seniority
Senior, hands-on IC