Sr Quality Engineer

Position Summary

Johnson & Johnson Surgical Vision is recruiting for an experienced Senior Quality Engineer located in Milpitas, California. The role works collaboratively with manufacturing, manufacturing engineering, and R&D to ensure quality standards across our product lines manufactured in Milpitas.

• Support the application of quality engineering and quality compliance in demanding projects across supply chain life‑cycle engineering, manufacturing, or assembly; new product development; new process introduction; and quality systems/business improvement.
• Develop standard operating procedures, specifications, and provide technical and validation support.
• Develop and implement projects to achieve governance objectives, track progress against schedules, provide timely status reports, and communicate status to management.
• Provide support and expertise in the implementation and enforcement of GMP, ISO, and FDA requirements.
• Provide statistical support and analytical problem solving for manufacturing, technical services, and product development to identify root causes of problems.
• Audit and approve manufacturing, quality, and engineering qualification documents for conformance to Johnson & Johnson business practices and departmental procedures.
• Support process improvement activities.
• Support processing of product nonconformances on the manufacturing floor.
• Support Nonconformance (NC) and Corrective Action and Preventive Action (CAPA) activities.
• Other responsibilities may be assigned and not all responsibilities listed may be assigned.

Education
: A minimum of a Bachelor’s or equivalent degree, preferably in Engineering or a Science related field.

Experience
:

• Minimum of 4 years of work experience.
• Experience in medical device industry with knowledge of 21 CFR 820 and ISO 13485.
• Computer proficiency with MS Office.
• Strong technical understanding of manufacturing equipment and processes.
• Experience with GDP and GMP.
• Experience with root cause analysis and Corrective Action / Preventive Action (CAPA).
• Experience managing projects and demonstrating project leadership abilities.

Preferred
:

• Industry experience with capital equipment.
• CQE Certification is preferred.

Could require up to 10% domestic and international travel.

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. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an inclusive interview process and accommodations for applicants with disabilities. For accommodation requests, contact J&J Careers.

Base pay range: $ - $. Additional benefits include a consolidated retirement plan (401(k)), paid vacation, sick time, holiday pay, personal and family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time‑off. Detailed benefit information is available at J&J Employee Benefits.