Quality Engineer II

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 is seeking a Quality Engineer to support projects that will help the company continue our mission to deliver medical systems that advance the practice of medicine. This position reports to the Director of Design QA and will be an on-site position located in our Milpitas, CA facility.

Requirements:

• Perform quality engineering development activities for new product designs by assisting Engineering in the preparation of design and development plans, Design History File documentation, and Design History File preparation.
• Review and approve Device Master Record documentation for new product design and maintenance, including bills of material, assembly procedures, manufacturing operations, assembly diagrams, test procedures, component specifications, labeling, and operator's manuals.
• Perform ongoing quality engineering activities on current products to improve product designs and/or manufacturing processes including participation in NCM, Complaint, and CAPA investigations and actions as necessary.
• Assist in process validation activities for new and current products.
• Assist in maintenance and improvement of the Quality System with guidance of QA Management, including internal audits, external audits, and quality improvement activities.
• Assist Engineering in the preparation and execution of verification and validation protocols and verification and validation test reports for new products and changes to current products.
• Participate in Hazard Assessment, Failure Mode and Effect Analysis, and risk management analysis, as required, for new and current products.
• Assist in the preparation of regulatory submissions to the U. S. FDA and other regulatory agencies.
• Review and approve Device History Records for products finished device release as required.
• Serve as a technical resource for technicians, assemblers, and other Stellartech personnel.
• Perform other duties as Supervisor may direct.

Education and Experience:

• BS degree or equivalent.
• At least 1-3 years relevant experience is required.
• Participation in ASQ is desired.
• Salary Range: $110,000 - $130,000 annually.
  The posted range represents the company's good-faith estimate for base salary for this role at the time of posting. Actual compensation will be determined based on relevant factors such as skills, experience, education, and internal equity.
• Benefits: We offer a competitive benefits package to our full-time employees, including medical, dental vision, life and disability insurance, and paid time off. In addition, Stellartech offers a 401(k) plan with company match and a stock equity plan.