Johnson & Johnson Careers
Manager, Quality Operations
Requisition ID: 9647190731
DePuy Synthes Companies of Johnson & Johnson is seeking a Manager, Quality Operations to be located in Warsaw, Indiana.
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.
The Manager, Quality Operations will utilize Leadership, People Development, Interdependent partnering, and Quality Engineering expertise to ensure efficient and effective Quality/Compliance and continuous improvement in the DePuy Orthopedics manufacturing facility. He/she will also utilize Quality Engineering/Operations principles and problem-solving skills to develop and optimize products/processes that are aligned with the overall Quality and Business vision. This individual will support processes in Base Business and supervise, lead, and mentor engineers and technicians.
The Manager, Quality Operations will identify and lead quality improvement initiatives that drive improvements to products, processes and Quality Systems. Successful results will often be delivered through cross-functional teams that will include Quality engineers/technicians in their department. Other responsibilities of this role will include, but are not limited to:
- Partner with Operations, Process Engineering, and other cross functional partners
- Provide supervision, mentoring, coaching, performance review, developmental plans, and succession planning for the Quality Operations team. This person shall develop a high performing and well-respected team, and will identify and implement organizational improvements as necessary
- Lead the NCR process to deliver outstanding results, metrics, and compliance.
- Champion 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
- Carry out management responsibilities in accordance with the organization's policies and applicable laws
- A Bachelor’s degree and a minimum of 8 years’ experience in a GMP and/or ISO regulated industry is required. A degree in Engineering or a related technical field is preferred
- Experience working in an FDA regulated environment is required. European regulatory environment is preferred
- Experience working in operations supporting a production environment is required
- Product/process Risk Management experience is required
- Advanced technical training and experience using Statistics, Lean and Six Sigma Methodologies (i.e. Measurement System Analysis, SPC, DOEs, Reliability, etc.) is preferred
- Ability to analyze and present data that facilitates & drives decision making is required
- The ability to perform "hands on" troubleshooting and problem solving is required
- Technical understanding of manufacturing equipment and processes is preferred
- Process Validation expertise is preferred
- This position is located in Warsaw, Indiana and may require up to 10% 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.
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