J&J Family of Companies Principal Quality Engineer in Raynham, Massachusetts
DePuy Synthes Companies of Johnson & Johnson is seeking a Principal Quality Engineer to be located in Raynham, MA or Warsaw, IN.
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.
DePuy Synthes Companies of Johnson & Johnson is seeking a Principal Quality Engineer within the Quality Engineering Continuous Improvement Group. The person will be located at a DePuySynthes North America site (preferred location Raynham or Warsaw). 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 Principal Quality Engineer is responsible for identifying and integrating key customer centric quality and business process improvement programs and strategic roadmaps including managing resource requirements, timeline and change management tools for DePuy Synthes. He/she will lead Proactive Quality events leveraging internal and external data base and formulate improvement strategies by enlisting and influencing cross-functional teams, delivering tangible business results through the application of FPX, Six Sigma and Lean methodologies and tools. In Summary this person will be responsible for the following:
Advance Quality principles in order to drive continuous improvement and improve product and process quality.
We need you to function as both an individual contributor and an overall leader of activities in a matrixed organization.
You will develop quality strategies in support of the respective DePuySynthes plants and the business objectives.
You'll be responsible for planning and coordinating future technology driven Quality Operations Organizational capabilities development.
Working in partnership with the Quality Ops and Engineering Leadership Team, you will be responsible for ensuring that products are manufactured in accordance with J&J requirements and FDA regulations, as well as all applicable international regulatory requirements.
You will work closely with key business stakeholders (i.e. plant, business unit, and sector staff, across multiple functions including Operations, Engineering and Quality) to drive strategic development, execution and flawless communication.
Identify process improvement opportunities that will results in target efficiency thresholds.
You will utilize Quality Engineering principles and problem-solving skills to develop and optimize products/processes that are aligned with the overall Quality and Business vision.
You will ensure effective risk management to prevent unanticipated failure modes and improve capability of processes.
Comply with J&J Safety Requirement and safe working conditions and practices in the department.
Position duties & responsibilities:
Assists in developing strategy as well as Goals and Objectives for Quality Operations.
Enables effective deployment across the Quality Operations Organization of procedures and methodologies to ensure high product quality as well as compliance with J&J requirements, FDA and global quality system requirements.
Ability to handle a variety of individual projects while directing the efforts of resources at the same time.
Represent Quality as a core/or ad-hoc team member for Engineering Virtual Teams.
Lead effectively in a high complex matrixed environment working at Enterprise, Sector and company level.
This role requires close collaboration with Engineering, Product Management, Quality Ops, Lean & Operations.
This role requires active benchmarking to identify best practices, capture Stakeholder VOC and effectively convert those Quality User Requirements in the development of technology innovative applications.
Effectively communicate at different levels within the organization (strategic business acumen & quality technology SME). Areas of focus include but are not limited to: CCPs, Testing & Inspection, Digital Systems, Packaging etc.
Collaborate with Virtual Teams in the development of strategic Technology Roadmaps
Drive Total Cost of Quality, better compliance environment, product quality and recall prevention
Ability to Understand and Translate Customer Needs (Explicit And Implied); Customer Facing Metric Development
A minimum of a Bachelors’ Degree, preferably in Engineering or related technical field.
M.S., M.B.A., or advanced degree highly preferred.
Requires 8+ years related experience including 4+years specific experience in a management/supervisory role.
Experience in the medical device, pharmaceutical or other highly regulated field is required.
ASQ Engineer certification a plus.
Process Excellence training or certification preferred (Lean, Six Sigma, DeX,FPX)
Working knowledge of US and International regulations governing the medical device industry (i.e., GMP, GLPs, MDR, and ISO 13485: 2003) is highly preferred.
Strong managerial skills and ability to manage multiple departmental budgets required.
Excellent communication skills (verbal and written) and problem solving skills required.
Knowledge of fundamental quality engineering principles such as Process Validation, Design of Experiments, and Process Control & Capability required.
Knowledgeable in matrix management and able to work collaboratively cross-functionally as well as across business units required.
A person of strong conviction with effective persuasion skills must be comfortable making objective decisions and taking decisive action.
Capable of assuming technical hands-on leadership required.
Team player, able to bring diverse people and opinions together to provide the optimum solutions for the company, its employees and customers required.
In instances, this position may require travel to multiple locations (30-50%)
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.
Johnson & Johnson Family of Companies areequal opportunity employers, and all qualifiedapplicants will receive consideration for employmentwithout regard to race, color, religion,sex, sexual orientation, gender identity, geneticinformation, national origin, protected veteranstatus, disability status, or any othercharacteristic protected by law.
North America-United States-Indiana-Warsaw
Depuy Orthopaedics. Inc. (6029)