Quality Engineer II, Network Projects - Johnson and Johnson

DePuy Synthes, a member of the Johnson & Johnson Family of Companies, is currently hiring for a Quality Engineer II. The role can be located in: Raynham, MA / Cork, Ireland / Warsaw, IN.

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.jnj.com/.

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 Quality Engineer II will be a critical member of the Supply Chain Quality organization supporting the construction and qualification of a new DePuy Synthes manufacturing facility at the future J&J MedTech campus in Alajuela, Costa Rica. This individual will support definition of key Quality activities for successful project completion including Validation Plans, Inspection Plans, and Equipment and Process Qualification.

Does this sound like you? Come join our Supply Chain Quality team today!
Key Responsibilities:

• Support planning and execution of process verification and validation activities
• Lead inspection planning activities to ensure all Critical to Quality (CtQ) features are verified with appropriate, qualified inspection and test methods
• Provides support on activities, documents and records requiring Quality review and/or approval
• Conducts and/or participates in troubleshooting and/or deviation investigation efforts during project execution
• Support Quality process knowledge transfer activities
• Partner with cross-functional partners to ensure completion of activities in alignment with project strategy and timeline
• Business Improvements: Conduct benchmarking to develop more effective methods for improving quality. Support quality improvement initiatives such as process and product characterizations
• Compliance/Regulatory: Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
• New Product/Process Introduction: 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. Supports new product introduction as part of design transfer.
• Risk Mitigation: Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard.
• Timely escalation of risks and emerging issues to project leadership

Education:

• A minimum of a Bachelor's degree in a Technical of Scientific subject area

Experience and Skills:

Required:

• A minimum of 2 years of experience in Supply Chain, Quality and/or R&D within a GMP or ISO regulated industry
• Excellent problem solving and decision-making skills
• Experience supporting Process Verification / Validation activities
• Interpersonal skills that foster collaboration as it relates to technical situations
• Strong initiative and follow-through in completing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience

Preferred:

• Other Advanced degree or a degree with a focus in Engineering, Science, Computer Science, or Digital area
• Quality Engineering experience
• Experience leading risk management activities and developing associated documentation, such as Failure Modes & Effects Analysis
• Experience with inspection & test methods including GD&T
• Experience working with ERP systems and associated Quality process flows
• Strong experience with Six Sigma or Lean

Other:

• This position may require up to 25% domestic & international travel

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.

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 .