Supplier Quality Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Supply Chain Engineering

Job Sub Function: Quality Engineering

Job Category: Scientific/Technology

All Job Posting Locations: Raynham, Massachusetts, United States of America

Job Description:

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.

The Supplier Quality Engineer I for Joint Reconstruction provides overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of DePuy Synthes Joint Reconstruction products.

• Supports established contract manufacturing sites via audit support, driving compliance and quality improvement initiatives.
• Assists in the resolution of process and product nonconformance events.
• Collects and escalates product or process complaints.
• Calculates contract manufacturer performance metrics and assists in conducting management reviews.
• Aids the external manufacturer with change management activities.
• Prepares audits of all quality system categories to assess compliance to process excellence standards.
• Implements basic measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, demonstrating continuous improvement to management.
• Assists in technical issues for manufacturing processes that are to be transferred to satellite facilities.
• Provides Quality Engineering support to suppliers including audits/assessments, inspection technique support, verification/validation activities, CAPA and change management.
• FDA CFR Part 820 and ISO 13485 regulations/standards will be the focus.
• Additional duties as assigned.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.

• A minimum of a Bachelor's Degree or equivalent is required.
• A Degree in Engineering or related discipline is preferred.
• Generally Requires 0-2 years work experience.
• Experience in a GMP and/or ISO regulated industry is preferred.
• Experience in the medical device and/or pharmaceutical industry is preferred.
• FDA and ISO regulations knowledge is preferred.
• Auditing background is preferred.
• Strong communication, teamwork, and problem solving skills are required.
• Strong root cause analysis skills are required.
• Experience or knowledge with machining manufacturing processes, 3D printing, and injection molding is preferred.
• Six Sigma, Lean, or ASQ Certification and trainings are preferred.

This job description does not constitute an employment agreement between the employee and DePuy Synthes. The duties above are intended only as illustrations of the various types of…