Manager 1, Quality

DePuy Synthes, a member of the Johnson & Johnson Family of Companies, is currently hiring for a Manager 1, Quality. This position will be based in Palm Beach Gardens, FL.

A pre-identified candidate for consideration has been identified. However, all applications will be considered.

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.

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.depuysynthes.com.

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 Quality Manager will utilize Quality tools and methods for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality principles and problem-solving skills to develop and optimize products/processes that are aligned with the overall Quality and Business vision. They will ensure effective risk management to prevent unanticipated failure modes and improve capability of processes.

Key Responsibilities:

• Mentors and supports quality improvement initiatives such as:
• Process and product characterizations that lead to continuous / cost improvements.
• Effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
• Benchmarking with external companies or internal sites to develop more effective methods for improving quality
• Improvement of Quality Indicators
• Customer Experience improvements projects
• Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN, Medical Device Directive (MDD) and Medical Device Regulation (MDR requirements) including providing support during internal and external audits.
• Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
• Supports the development of quality strategies related to the transfer of products, materials and components within J&J or externally. Supports new product introduction as part of design transfer.
• Key Stakeholder in reviewing the investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints.
• Escalation of quality issues as appropriate.
• Analyzes/reviews effectiveness of preventive and corrective actions. Reviews/Approves root cause investigation according to an established process.

• Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.
• Identifies and executes opportunities to improve scrap and rework indicators.
• Supports site strategies on IQ, OQ, PQ, TMV or Software Validation
• Approve IQ, OQ, PQ, TMV or Software Validation as required
• Works with multi-functional teams to establish operational plans and ensures uninterrupted support to manufacturing operations.
• Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan.
• Develop measurement systems/capabilities, destructive tests, non-destructive test for manufacturing processes.
• Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business.
• Develops and leads a team of Quality Engineers to monitor effective quality processes, lead/support strategic projects and assure compliant and efficient execution of manufacturing processes.
• Serves as a consultant in quality related operations and quality systems applicable to the plant products and processes in support to day-to-day manufacturing processes. Provides guidance and recommendation as needed.
• Ensures adequate resources with the appropriate proficiencies to execute the Quality System.
• Partner with Value Stream Leaders, End to End Supply Chain partners, R&D Quality, Operations, Regulatory & Marketing to assure all NPI quality results are met within cost, quality and schedule targets.
• In partnership with other supply chain functions, develop Quality capital budget plans and supervises its performance over time, including long range planning and adherence to financial commitments.
• In collaboration with other functional partners ensures that programs and projects stay on plan by removing obstacles, which may involve negotiations at a senior level.
• Collaborates with the Quality Centers of Excellence and assure execution of business processes at the site level.
• Ensures a customer centric approach and partners with Franchise Quality teams to deliver customer commitments.
• Responsible for the recruitment, supervision, training, and development of Quality personnel.
• Leads/Host FDA/BSI and other foreign regulatory audits to the sites as required.

• 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

• Eight (8) years of related work experience
• A minimum of 5 years of experience in Supply Chain, Quality and/or R&D within a GMP or ISO regulated industry
• A minimum of three (3) years of direct people management experience
• A minimum of three (3) years of experience in Quality
• Strong knowledge of FDA, EU, and other Global regulations
• Experience leading Validation/Verification activities including CSV and Test Method Validation
• Strong collaboration, influencing skills and experience working in a highly matrix environment
• Strong skills with a proven track record in handling risk-based decision making
• Proven record of employee engagement, change management and ability to drive a strong Quality Culture
• Track record of talent development

• Experience hosting Notified Body/FDA audits is strongly preferred
• Experience bringing digital capabilities to a Supply Chain environment
• Capital Equipment Management, Electromechanical assembly, and robotics/digital manufacturing processes
• Medical Device experience
• Experience leading/supporting strategic projects
• Process Excellence or Lean experience

• Position may require less than 5% travel

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

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.