Quality Engineer II - Medical Devices, Onsite Milpitas

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

Benefits offered by this job

Medical, dental, vision

Life and disability insurance

401(k) with company match

Stock equity plan

Paid time off

Job summary

Stellartech in Milpitas, CA is seeking a Quality Engineer to support the design QA and regulatory activities for medical systems. The role reports to the Director of Design QA and is on-site at our Milpitas facility.

The candidate will assist in DHF documentation, review Device Master Records, participate in CAPA and risk assessments, and help with regulatory submissions and audits as needed. A BS degree with 1–3 years’ experience is required, ASQ involvement is a plus.

Qualifications

• BS degree or equivalent.
• 1–3 years relevant experience required.
• Participation in ASQ is desired.

Responsibilities

• Assist in quality engineering development activities for new product designs, including DHF documentation and design history file prep.
• Review and approve Device Master Record documentation (BOMs, assembly procedures, labeling, manuals).
• Participate in CAPA investigations and risk assessments for new and existing products.
• Assist in regulatory submissions to FDA and other agencies.
• Support internal/external quality audits and quality improvement activities.

Skills

Quality engineering

Design QA

Regulatory knowledge

CAPA investigations

Education

BS degree or equivalent

Job description

Stellartech in Milpitas, CA is seeking a Quality Engineer to support the design QA and regulatory activities for medical systems. The role reports to the Director of Design QA and is on-site at our Milpitas facility.

The candidate will assist in DHF documentation, review Device Master Records, participate in CAPA and risk assessments, and help with regulatory submissions and audits as needed. A BS degree with 1–3 years’ experience is required, ASQ involvement is a plus.