Senior Quality Engineer
About The Position
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. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. 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. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Requirements
- Master's degree in Mechanical Engineering, Biomedical Engineering or related field and 3 years of experience in the job offered or in a Senior Quality Engineer-related occupation.
Responsibilities
- Provide Design Quality Assurance to efficiently deliver safe and effective medical device designs for manufacturing.
- Provide Quality Assurance support to 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 and appropriate process controls.
- Support project teams to ensure that new and existing products are designed and developed in accordance with customer, corporate, and regulatory guidelines, and work closely with Design and Manufacturing Engineering to improve processes where possible.
- 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.
Benefits
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year (may vary by state)
- 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
- Medical
- Dental
- Vision
- Time off
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What This Job Offers
Job Type
Full-time
Career Level
Senior
