Johnson & Johnson Careers
Senior Quality Manager, Robotics Hardware and Systems
Requisition ID: 1604190409
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, is recruiting for a Senior Quality Manager, Robotics Hardware and Systems based in Warsaw, IN; Raynham, MA or Palm Beach Garden, FL. This position will require up to 30% travel, including some international.
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.
Reporting to the Sr. Director Quality Engineering A&D, the Sr. Quality Manager Robotics Hardware and Systems has primary responsibility to lead the development and implementation of two business critical programs within the company. This role will provide leadership on a Joints and Robotics project that includes the design and development activities and the execution of the development cross quality system from Synthes and DePuy. The role also includes responsibility for developing quality capabilities of the team supporting the project across multiple locations in the DePuy Synthes network. This position provides design quality support in line with established J&J and Franchise standards and regulatory requirements.
This role will interact and collaborate with the following teams on a regular basis: R&D, Product Management, Supply Chain, Source, Regulatory Affairs, J&J Regulatory Compliance (JJRC), Enterprise Source Quality, Health Authority and Notified Body personnel as required.
- Lead Quality Development and implementation for business-critical Robotics and Joints projects.
- Develop and implement the Quality Strategy for multi-site development and launch across DePuy and Synthes Quality System.
- Lead and manage a quality team of approximately 5 direct reports and up to 5 indirect reports.
- Own budget planning and execution for development projects.
- Implement, analyze, report and maintain project metrics and dashboard. Establishes and monitors departmental metrics including quality costs.
- Responsible for developing and monitoring the project resource model, budget, and headcount requirements.
- Partner with R&D, Supply Chain, Marketing and Software to develop and execute project plan.
- Promote continuous improvement and Process Excellence activities supporting the new product development projects.
- Partner with Supplier Quality and Source to select strategic suppliers for execution of key components.
- Lead team that will qualify components and finished goods at supplier sites.
- Partner with R&D and Supplier Quality to implement new product sourcing and supplier controls in line with business and J&J requirements.
- Complies with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001).
- Coordinate review of complaint data for new acquisition to drive improvement.
- Develop intercompany quality agreements across the different operating companies involved.
- A minimum of a Bachelor’s degree in Business, Life Science, Physical Science or Engineering required; A Master’s degree is preferred.
- Minimum of 8 years of combined experience in Regulatory, Compliance, Quality Management and/or Operations in Medical Devices, Consumer, Pharmaceutical or other highly regulated environment is required; medical device experience is preferred.
- Minimum of 4 years with Supervisory experience is required.
- Experience successfully managing multi-geographical organization is required.
- Experience driving high performing cross-functional and indirect teams that deliver results is required.
- Strong background in Process Excellence, Six Sigma, Lean methodologies or operational excellence preferred.
- Experience leading teams to deliver product development programs is required.
- Experience leading teams to establish standard quality system processes and operating procedures across quality systems is required.
- Deep knowledge of regulated healthcare environment and strong business acumen is highly preferred.
- Functional knowledge of / experience in Quality & Compliance is required.
- Excellent communication skills and the ability to interface effectively with all levels of the organization is required.
- Ability to influence others, managing competing internal stakeholder priorities and dealing with ambiguity is required.
- Executive presentation skills are required.
- Proficiency with engineering analysis and statistical software preferred.
- Experience in implementing innovative approaches to Quality and Regulatory solutions in a fast-paced changing business environment is required.
- Ability to foster a productive team-oriented environment, handle multiple assignments, and display flexibility in response to an environment with rapidly shifting priorities is required.
- This position will be based in Warsaw, IN; Raynham, MA or Palm Beach Garden, FL and may require up to 30% travel, including some international.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
North America-United States-Indiana-Warsaw, United States-Florida-Palm Beach Gardens
Depuy Orthopaedics. Inc. (6029)