Location: Raynham,MA, USA
DePuy Synthes is recruiting for a Quality Operations Leader, to be located in Raynham, MA.
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The Quality Manager plans, directs, and conducts projects of major scope and significance to the Company with full technical responsibility for interpreting, organizing, executing and coordinating assignments. They may contribute inventions, new designs or techniques which are materially significant in the solution of important problems. Quality Engineering Manager will act as a mentor to more junior staff and advice top management on technical matters.
The Quality Manager will apply Quality Engineering tools and methods for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. The incumbent will also apply Quality Engineering 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. This person will support processes in Base Business and supervise, lead and mentor other engineers and technicians across the site.
Key Responsibilities:
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
* Leads or support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
* 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.
* Establish and maintain department/cost center budget
* 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.
* Provides supervision, mentoring, coaching, performance review, developmental plans, and succession planning for others (including Quality Engineers and Technicians) across multiple sites and/or various geographic regions.
* Lead and maintain Material Review Board.
* Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
* Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
* Collaborates with other quality leaders to identify required quality engineering skills and competencies to allow for the execution of the strategic vision.
* Conduct strategic planning with site leaders and Product Engineering Team. Partnership with other functions to establish business priorities and resource allocation