Senior Quality Engineer

Senior Quality Engineer

Location:

Santa Clara, CA;
Type:
Full‑time;
Pay: $145,205 – $155,369

• Provide Design Quality Assurance to efficiently deliver safe and effective medical device designs for manufacturing.
• Support functions with a focus on process improvements and design control compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP and other applicable regulations.
• Work closely and partner with internal departments to ensure designs are aligned with company policies and procedures.
• Participate in design reviews and pre‑validation assessments to ensure the safe and environmentally sound initiation of new processes with adequate process controls.
• Support project teams to ensure that new and existing products are designed and developed in accordance with customer, corporate, and regulatory guidelines.
• Participate in decisions on scope of work, risk management, design changes, process improvements, material disposition, and implementation of revised specifications.
• Provide guidance to manufacturing and development engineers regarding documentation, process controls, data feedback systems, and best quality practices.
• Develop and maintain calibration requirements for tools and equipment in the R&D, Manufacturing, and Quality areas.
• Analyze nonconformance reports and returned products, and recommend corrective action.
• Write detailed and accurate technical documents to be submitted for regulatory review.

• Master's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• 3 years of experience in a Senior Quality Engineer‑related occupation.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.

• Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Long‑term incentive program.
• Vacation – 120 hours per calendar year.
• Sick time – 40 hours per calendar year; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington.
• Holiday pay, including floating holidays – 13 days per calendar year.
• Work, Personal and Family Time – up to 40 hours per calendar year.
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child.
• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year.
• Caregiver Leave – 80 hours in a 52‑week rolling period.
• Volunteer Leave – 32 hours per calendar year.
• Military Spouse Time‑Off – 80 hours per calendar year.