Senior Quality Engineer - Orthopedics

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. Learn

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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:

About Med Tech

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at

We are searching for the best talent for a Senior Quality Engineer to be located in Raynham, MA.

The Senior Quality Engineer provide an overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products. Also, conducts audits to good manufacturing practices, international organization for standardization and any other applicable standards.

You will be responsible for:

* Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.

* Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.

* Conduct benchmarking to develop more effective methods for improving quality

* Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.

* Formulates and executes quality improvements.

* Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to 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.

* Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.

* 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 new product introduction as part of design transfer.

* Supports activities related to the Material Review Board.

* Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.

* Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.

* Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.

* Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.

* Represents as an Subject Matter Expert (SME)

* Support or leads in developing validation strategies.

* Approves IQ, OQ, PQ, TMV or Software Validation.

* Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.

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