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.
[The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century.
With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide.
Together, we are working to shape the future of health through differentiated products and services.
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, system implementation, service and repair readiness for Capital products.
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, presenting 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 experience.
Experience in the regulated industry (MedTech or Pharmaceutical/Medicine).
A minimum of one to two (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, Service and Repair business model, Capital Evaluation products, Product Returns, Final Acceptance, Change Management and Nonconformance.
Strong communication, teamwork, problem solving and decision-making skills In-depth knowledge of Product/Process Risk Management.
Understanding of the regulatory requirements for a commercial release (MDSAP, MDD, MDR, FDA, and ISO standards).
Prior experience with GD&T, Six Sigma, Lean Manufacturing, and Continuous Improvement.
Preferred.
Experience in Product/Process Transfer, Defining Business Requirements, System Integration/Enhancement, Electro-Mechanical Capital Equipment, Service and Repair Business Model, Inventory Management.
Experience in Quality Agreement and working with multiple Quality Management Systems.
Project Management is an asset.
Prior experience in Process / Manufacturing Quality is an asset.
Other.
Up to 25% of travel both domestically and internationally is required We are utilizing 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.
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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.