Senior Manager, Quality Operations Inspect and Test
DePuy Synthes, a Johnson & Johnson company is hiring a Senior Manager, Quality Control Inspect and Test has joint responsibilities between Bridgewater and Raynham, MA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Senior Manager, Quality Control is responsible for managing and coordinating the activities of the Quality Operations Inspection and Test areas (Device History Record Review, Incoming and Finished Product Inspection, Operator Certification and Final Product Release). You'll assure compliance with regulations and promote good manufacturing and/or laboratory practices and good product quality engineering practices. Leads the development and implementation of initiatives to assure process robustness and regulatory compliance in the areas of responsibility.
Leads the department responsible for inspection and testing of raw materials, finished products and implementation of new product introductions across DePuy Synthes Spine, Sports Medicine (Mitek), Joint Reconstruction and Cerenovus (Neurovascular) businesses.
Other responsibilities include
- Recruitment, supervision, training and development of all QA test and inspect personnel, approximately 50 QA associates.
- Maintain quality standards and procedures for processing materials into partially finished or finished material or product as well as, machining, inspection, receiving inspection raw and semi-finished product, labelling, laser etch identification, cleaning, packaging, labelling, packaging, including partnership of validation, calibration and metrology activities.
- Ensure accurate maintenance of applicable device history files.
- Oversight of the implementation and execution of inspections prior to the processing of raw materials/components, and the timely management reporting of internal/external quality results with conclusions for all required corrective actions.
- Work closely with Operations in a team based environment to insure process and product compliance with all relevant quality standards, including the formal certification of operations personnel to perform quality related inspection/audit activities.
- Works with multi-functional teams to establish operational plans and ensures uninterrupted support to manufacturing operations.
- Serves as a consultant in the quality related operations and quality systems applicable to the plant products and processes. Provides guidance and recommendation as needed.
- Ensure new products are transferred into routine testing and inspection effectively with all development documentation completed.
- Identifies, prioritizes, and oversees execution of quality and cost improvement projects that support business goals by using engineering principles, tools, and practices.
- The disposition of products or materials that do not meet standards and specifications.
- Ensure fulfillment of all Health & Safety requirements in accordance with the responsibilities defined in the Company Safety Statement, as well as actively promote Health & Safety within the department and ensuring it's a priority for all direct reports.
- Ensure audits are conducted in accordance with requirements of ISO 13485, FDA QSR 21 CFR Part 820 or other recognized regulatory standards for all markets in which our products are sold.
- You will be a member of the Quality Operations leadership team for the Raynham/Bridgewater sites.
- A minimum of a Bachelor Degree is required, preferably in Engineering or Science Discipline.
- 10+ years of experience in a GMP and/or regulated industry is required.
- Medical device industry experience is preferred.
- 3+ years of direct people management experience is required.
- Experience in Project Management; Risk Management; Cost Accounting Principles; Quality Auditing; Operations Processes; Systems Development & Integration are required.
- Strong analytical, communication, negotiation, and change management skills
- Strong business insight, interpersonal and performance management skills for a highly global matrix organization and teams with diverse cultures and business practices is required.
- Ability to interact with, influence, and lead cross-functional, cross-business unit teams is required.
- Strong tactical planning and execution abilities, including strong organization skills is required.
- Experience taking initiative with innovative ways to problem solve in a fast-paced, changing business environment is required.
- Process Excellence and Lean experience desired.
- Proven Record of Successfully Leading Complex Team Structures
- Results driven, decisive, proactive, and responsive
This position will be based in Bridgewater/Raynham, MA and will require up to 10% travel.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
North America-United States-Massachusetts-Bridgewater
Depuy Orthopaedics. Inc. (6029)
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