SENIOR QUALITY ENGINEER

DePuy Synthes, a member of the Johnson & Johnson Family of Companies is recruiting for a Senior Quality Engineer, located in Palm Beach Gardens, Florida.
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 https://www.
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DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world.
DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide.
For more information, visit www.
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Johnson & Johnson Medical Devices is focused on shaping the future of digital surgery and expanding its robotics and digital solutions offerings across the entire portfolio, with multi-specialty, end-to-end solutions in orthopedics, endoluminal intervention and general surgery.
This includes the VELYS platform where we are building connected technologies powered by data insights before, during and after surgery, and designed to elevate the orthopedic experience for patients, surgeons, and care teams.
This includes the VELYS Robotic-Assisted solution which simplifies knee replacement surgeries by providing valuable insights, versatile execution, and verified performance to deliver efficiency for surgeons and optimize patient outcomes.
The Senior Quality Engineer provides overall quality assurance leadership of on-site manufacturing areas engaged in the production of Johnson and Johnson products.
Ensures manufacturing areas are meeting good manufacturing practices, international organization for standardization and any other applicable standards.
The individual will be responsible for quality assurance leadership for product and process transfer, digital system implementation, system integration and process automation.
Key Responsibilities.
Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.
Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
Addresses and corrects product and process complaints.
Reports on contract manufacturer performance metrics and ensures management reviews.
Oversees audits of all quality system categories to assess compliance to process excellence standards.
Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, communicating reports to management which outline.
Handles complex technical issues for manufacturing processes that are to be transferred to satellite facilities.
Lead cross-functional teams to handle complex technical issues for manufacturing processes.
Conduct Risk Management planning and Risk Assessment methodologies.
Additional duties as assigned.
Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
Diligently participate in our compliance program-related activities as denoted by your supervisor.
Qualifications Education.
University/Bachelor’s or equivalent degree is required.
Other advanced degree or a degree with a focus in Engineering, Science, Computer Science, or digital area is preferred.
Experience and Skills.
Required.
A minimum of four (4) years of related work experience.
Experience in the regulated industry (MedTech or Pharmaceutical/Medicine).
A minimum of 1-2 years of experience in Quality Engineering.
Experience and a proven track record of implementing appropriate risk mitigation Experience in Process Mapping, Equipment Qualification and Test Method Validation, Inspection setup, Change Management, Nonconformance.
Strong communication, teamwork, problem solving and decision-making skills In-depth knowledge of Control Plans, assessment for CTQs and Inspection Features, Sampling standards, Supplier controls, Computer System Validation for Equipment.
Prior experience with GD&T, Six Sigma, Lean Manufacturing and Continuous Improvement.
Preferred.
Experience in Product/Process Transfer, Defining Business Requirements, System Integration/Enhancement, Receiving Inspection, Inventory Management.
Experience in implementing automated systems for production use.
Prior experience in Process / Manufacturing Quality is an asset.
Project Management is an asset.
Other.
Up to 25% of travel both domestically and internationally is required We are using J&J flex work schedule for 3 days in the office and 2 remote days.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
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Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.