Quality Engineer II - Medical Devices (Onsite) & Impact

STELLARTECH RESEARCH CORP; Milpitas (CA); On-site; USD 110,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan with company match

Stock equity plan

Job summary

STELLARTECH RESEARCH CORP is seeking a Quality Engineer to support projects that enhance medical systems. The role involves quality engineering activities, regulatory submissions, and collaborating with engineering teams at their Milpitas, CA facility.

The ideal candidate will need a BS degree, 1-3 years of relevant experience, and knowledge of quality systems and FDA regulations. Stellartech offers a salary range of $110,000 to $130,000 along with a comprehensive benefits package including 401(k) and stock options.

Qualifications

• 1-3 years of relevant experience in quality engineering.
• Participation in ASQ is desired.

Responsibilities

• Perform quality engineering development activities for new product designs.
• Review and approve Device Master Record documentation.
• Assist in the maintenance and improvement of the Quality System.
• Participate in Hazard Assessment and risk management analysis.
• Assist in the preparation of regulatory submissions to the U.S. FDA.

Skills

Quality engineering development

Regulatory submission preparation (FDA)

Process validation

Internal and external audits

Hazard Assessment

Education

BS degree or equivalent

Job description

STELLARTECH RESEARCH CORP is seeking a Quality Engineer to support projects that enhance medical systems. The role involves quality engineering activities, regulatory submissions, and collaborating with engineering teams at their Milpitas, CA facility.

The ideal candidate will need a BS degree, 1-3 years of relevant experience, and knowledge of quality systems and FDA regulations. Stellartech offers a salary range of $110,000 to $130,000 along with a comprehensive benefits package including 401(k) and stock options.