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

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 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.