Senior Supplier Quality Engineer
Core
Develop and implement supplier quality systems, conduct audits, and manage component qualifications to ensure compliance with FDA and international regulations for medical device manufacturing.
Role type
Senior Supplier Quality Engineer (Medical Devices)
Builds
Qualified components and sub-assemblies for medical device production
Domain
Medical Devices / Regulatory Compliance
Required skills
Supplier audits, FDA regulations, ISO 13485, NCR/SCAR management, First Article assessment, Measurement Systems Analysis, Control Plans, Data analysis, Blueprint reading, Engineering design
Preferred skills
MDD/CMDR/JPAL knowledge, ASQ CQE, ASQ CQA/ISO13485 Lead Auditor, Statistical analysis, Metal Injection Molding (MIM) supplier experience
Responsibilities
Develop and maintain supplier procedures and requirements; Direct supplier qualification and monitoring activities; Manage correction activities including NCRs and SCARs; Assist with FDA and ISO audits; Mentor junior SQE staff
Seniority
Senior, hands-on IC
