Sr. Manager, Quality

Depuy Synthes, a member of the Johnson and Johnson family of companies, is hiring for the Sr. Manager, Quality Engineering role 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 Sr. Quality Engineering 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 advise top management on technical matters.

The Sr. Quality Engineering Manager will utilize 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 utilize Quality Engineering principles and problem solving skills to develop and optimize products/processes that are aligned with the overall Quality and Business vision. He/she 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.

The position will also serve as the site Performance Lead. In this role, the incumbent will support development and tracking of Quality Goals and Objectives, Total Quality Improvement Metrics, Budget, and other performance metrics.

Serves as back-up Site Quality Management Representative.

DUTIES & 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:

•    Provide supervision, mentoring, coaching, performance review, developmental plans, and succession planning of Quality Engineers
•    Manage contract Quality Engineers that support projects, includes time approval and cross charges to projects
•    Supports the development of quality engineering, quality compliance, quality leadership talents with the right skills sets for new product introductions, and product life cycle management. 
•    Provide leadership and contribute to projects including compliance, continuous improvement, and franchise level projects
•    Lead or support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
•    Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to internal procedures and standards such as the QSRs, ISO 13485, etc.
•    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.
•    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 or externally.  Supports new product introduction as part of design transfer.
•    Conduct investigation, bounding, documentation, review and approval of non-conformances and CAPAs..  Escalation of quality issues as appropriate.
•    Review and approve Validation Documents including IQ, OQ, PQ, TMV and Software Validation.
•    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
•    Partner with other functions to establish business priorities and resource allocation
•    Develop and track Quality Performance Goals including TQI, Cost Improvement, Budget, Capability Matrix, and others