Jj
Sr Quality Engineer
Milpitas, California, United States of America · Senior
Sponsorship not specified$109k-$175kDetected 1 day ago
Supply ChainProcess ImprovementGMPFDA RegulatoryMedical DevicesLeadershipProblem SolvingCritical ThinkingMentoringMicrosoft Office
About the role
- Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.
- We provide an inclusive work environment where each person is considered as an individual.
- An internal pre-identified candidate for consideration has been identified.
Responsibilities
- Supports the application of quality engineering and quality compliance in support of demanding projects in the areas of:
- Develops standard operating procedures, specifications, and provides technical and validation support.
- Develops and implements projects to achieve governance objectives
- 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
- Develops and implements projects to achieve governance objectives; tracks progress against schedules; provides timely status reports; and communicates status to management
- Support Nonconformance (NC) and Corrective Action and Preventive Action (CAPA) activities
Requirements
- A minimum of a Bachelor's or equivalent degree, preferably in Engineering or a Science related field.
- Computer proficiency with MS Office
- Experience with GDP and GMP
- Experience with root cause analysis and Corrective Action / Preventive Action (CAPA)
Nice to have
- Industry experience with capital equipment
- CQE Certification is preferred.
- This role is based in Milpitas, California and could require up to 10% domestic and international travel.
- Preferred Skills:
Skills
- The anticipated base pay range for this position is:
- $109,000.00 - $174,800.00
- Additional Description for
Compensation
- $109,000.00 - $174,800.00
Benefits
- https://www.careers.jnj.com/employee-benefits
- Vacation -120 hours per calendar year
- Holiday pay, including Floating Holidays -13 days 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 period10 days
- Volunteer Leave - 32 hours per calendar year
- At Johnson & Johnson, we believe health is everything.
- Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
- Experience in medical device industry with knowledge of 21 CFR 820, ISO 13485
Equal opportunity
- Johnson & Johnson is an Equal Opportunity Employer.
- If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers.
This listing is sourced directly from Jj's careers page and normalized into a canonical job model.