Quality Engineer II, Medical Devices — On-Site Milpitas

Stellartech Research Corporation; Milpitas (CA); On-site; USD 110,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Stock equity plan

Paid time off

Job summary

Stellartech seeks a Quality Engineer to support medical systems projects, reporting to the Director of Design QA. This on-site role is based at our Milpitas, CA facility and involves collaboration with engineering to develop and maintain design history files and device master records.

Ideal candidates have BS degree and 1–3 years of quality engineering experience, plus knowledge of regulatory submissions and CAPA processes.

Qualifications

• BS degree or equivalent.
• 1–3 years of relevant quality engineering experience.
• ASQ membership or participation desired.
• Experience with medical device design controls a plus.

Responsibilities

• Assist in design and development planning and DHF documentation.
• Review and approve Device Master Records and BOMs.
• Participate in CAPA investigations and risk management.
• Assist in verification and validation protocols and reports.
• Assist in regulatory submissions to FDA and other agencies.
• Serve as technical resource for Stellartech personnel.
• Support internal/external audits and quality system improvements.

Skills

Quality engineering

CAPA investigations

Risk management

Education

BS degree

Tools

Design History File management

Regulatory submissions support

Job description

Stellartech seeks a Quality Engineer to support medical systems projects, reporting to the Director of Design QA. This on-site role is based at our Milpitas, CA facility and involves collaboration with engineering to develop and maintain design history files and device master records.

Ideal candidates have BS degree and 1–3 years of quality engineering experience, plus knowledge of regulatory submissions and CAPA processes.