Sr. Quality Engineer
Core
Ensures day-to-day compliance with quality and regulatory standards in manufacturing, providing indirect leadership to quality support personnel.
Role type
Senior Quality Engineer
Builds
Production features (manufacturing processes and product quality)
Domain
Manufacturing (electronics/PCBA) + Quality Management Systems
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
ISO 9001 and 13485 standards knowledge, cGMP FDA 21 CFR Part 820, AS9100, AS9102, ISO 14001 environment experience, electronics and electro-mechanical principles, Statistical Process Controls (SPC), Lean and Six Sigma Methodologies, inspection practices, solder knowledge, MS Office (advanced Excel), IQ/OQ/PQ
Preferred skills
PCBA low volume high mix or NPI experience, CSSGB or CSSBB certification, ASQ CMQ/OE, CQE or CQA certification
Technologies
ISO 9001, ISO 13485, FDA 21 CFR Part 820, AS9100, AS9102, ISO 14001, SPC, Lean, Six Sigma
Responsibilities
Manage complaint/NCR database and address Customer issued SCARs, Perform qualifications based on customer requirements, Support NPI process for new products, Develop customer specific quality plans, Execute internal quality audit program, Lead and train cross functional teams to perform layered process audits, Coordinate with Regional Supplier Quality Engineer to resolve supplier performance issues, Manage and collect systemic data for process improvement
Seniority
Senior, hands-on IC