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Raynham, MA, US

Quality Engineer II - DePuy Synthes Spine - PSI (1 of 2)-0300130130

Description

DePuy Synthes Spine, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineer II - PSI, located in 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 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, more agile and better equipped to meet the needs of 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 Spine is the Spine business offering a comprehensive portfolio of spinal care solutions for the treatment of the most simple to the most complex spine disorders using traditional and minimally invasive techniques.

The Quality Engineer II - PSI's role will perform post-market safety and surveillance activities including trend analyses, signal assessments and product investigations. He/she will execute the PMS process with a primary focus on signal assessment and detailed investigations of potential Safety Issues and Quality Trend Events. This role utilizes the signal analysis and detection data generated by the analytics team to assess trends/issues and perform detailed investigations to confirm the identified event. The Quality Engineer II - PSI will evaluate Signal Analysis/Detection Data, and interface with the PMS data analytics team to review signal analysis and detection data focusing on trends, triggers and control limits in PMS data that represent a potential Safety Issue/Product Quality Event. The role also includes evaluating potential Safety Issues/Product Quality Events against all known PMS Data sets with the intent of confirming the issues/event. The Quality Engineer II - PSI will lead Signal Assessment Investigations and perform issue/event investigations to understand root causes, risk and their impact.

The Quality Engineer II - PSI will also interface with key business partners including R&D, Operations, Medical and Marketing to ensure a thorough investigation is completed. The investigations can include user interviews and customer visits to ensure rapid response to field safety issues. Depending upon the nature of the identified safety issue/product quality event, the PSI Quality Engineer II will be the key interface with the Product Escalation group to ensure all events are escalated in a timely manner and per procedure.

This is a hands-on position that will require a self motivated individual with excellent written and oral communication skills. The ideal candidate for this role will have the ability to collaborate with business partners at all levels across multiple functional groups in an environment that embraces teamwork and risk-based decision making.

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Qualifications


A minimum Bachelors Degree in a technical discipline is required. A degree in Engineering is preferred. A Master's degree is a plus. A minimum of 2 years experience in highly regulated industry is required. Medical device/diagnostic/or pharmaceutical is preferred. Experience in medical device or healthcare is preferred. Excellent problem solving, decision-making, and root cause analysis skills is required. Experience with Post Market Surveillance activities is preferred. Previous Design Control experience is preferred. Proficiency with the Microsoft Office Suite is required. Strong working knowledge of the QSR and ISO quality requirements is strongly preferred. Knowledge of process and design excellence tools and Green or Black Belt training are a plus.

This position may require up to 10% domestic travel with an outside chance of international travel. This position will be based in Raynham, MA and does not offer relocation benefits.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Massachusetts-Raynham
Organization: Depuy Spine Inc. (6145)
Travel:Yes, 10% of the time