Sr Quality Engineer
About The Position
Johnson & Johnson Surgical Vision is recruiting for an experienced Senior Quality Engineer, located in Milpitas, California, USA. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. The Senior Quality Engineer will work collaboratively with manufacturing, manufacturing engineering and R&D to ensure quality standards are met across all our product lines manufactured in Milpitas. The Senior Quality Engineer is responsible for providing guidance on audits of all quality system categories to assess compliance to good manufacturing practices, and equipment engineering systems. This person plans and conducts projects and assignments with technical responsibility.
Requirements
- A minimum of a Bachelor’s or equivalent degree, preferably in Engineering or a Science related field.
- A minimum of 4 years of work experience
- Experience in medical device industry with knowledge of 21 CFR 820, 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
Nice To Haves
- CQE Certification is preferred.
- Industry experience with capital equipment
Responsibilities
- Supports the application of quality engineering and quality compliance in support of demanding projects in the areas of: Supply chain (life cycle engineering, manufacturing, or assembly), New product development / new product introduction / new process introduction, Quality systems / business improvement
- Develops standard operating procedures, specifications, and provides technical and validation support.
- Develops and implements projects to achieve governance objectives; tracks progress against schedules; provides timely status reports; and communicates 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 cause 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 in 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
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- 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
- 10 days Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
