Source Quality Engineer II

J&J Family of Companies

Raynham, MA 02767

Posted 1 month ago

Job Description

DePuy Synthes Companies is a member of Johnson & Johnson's Family of Companies and is recruiting for a Source Quality Engineer II located in Raynham, MA, Raritan, NJ or West Chester, PA.

DePuy Synthes Companies of Johnson & Johnson is the largest, most creative and comprehensive orthopedic business in the world. These companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two excellent 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 creative, comprehensive solutions, we are encouraged to advance patient care in greater ways than either company could accomplish on its own.

Overall Responsibilities

Provides comprehensive product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes. Applies industry and process excellence standards on a moderately complex level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO). Addresses or raises product and process complaints. Evaluates contract manufacturer performance metrics and conducts management reviews. Conducts audits of all quality system categories to assess compliance to process excellence standards. Implements comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, demonstrating continuous improvement to manufacturing processes. Facilitates technical issues for manufacturing processes that are to be transferred to satellite facilities.

Key Responsibilities:

+ Provides quality engineering leadership in the management of select contract manufacturing and supplier sites engaged in the production and delivery of Johnson and Johnson products and services.

+ Responsible for technical leadership in establishing quality expectations at the supplier, to include process changes in partnership with Source Quality and New Product Development (NPD) Teams

+ Implements, and/or maintains, production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, process performance metrics).

+ Partner with NPD team to support successful launches at suppliers.

+ Conduct supplier visits emphasizing quality improvement and compliance with good manufacturing practices, ISO and other applicable standards.

+ Provide product team support for quality system requirements and supplier auditing, compliance assessment, and for support of sustaining manufacturing processes.

+ Provide Quality Engineering support to suppliers including inspection technique support, product non-conformances, verification/validation activities, CAPA and change management

+ Address and support investigation of product issues to include product and processing complaints.

+ Contributes to root cause investigations using various problem-solving techniques and tools, and assesses effectiveness of corrective actions.

+ Apply industry and process excellence tools and standards in daily quality operation activities, to include Good Manufacturing Practices (GMP), equipment engineering system (EES), and ISO.

+ Demonstrates proficiency in applying various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, effects analysis).

+ Lead supplier visits focusing to assess compliance to process excellence standards.

+ Ensure comprehensive measurement systems to monitor effectiveness of quality and reliability. Identify, bracket, correct and prevent defects. Present reports to management.


Education & Required Skills/Experiences:

+ Bachelor’s degree with at least 2 years of experience in a highly regulated industry is required

+ ISO regulations knowledge

Preferred Skills & Experience:

+ A degree in Engineering, Life Science, or related field

+ Experience in the Medical Device industry

+ •FDA CFR Part 820 and ISO 13485 knowledge

+ Auditing background

+ Strong communication, partnership, and analytical skills

+ Strong in root cause analysis skills

+ Experience with process validation

+ Experience or knowledge with machining manufacturing processes, injection molding and/or electronics manufacturing

+ Six Sigma, Lean, or ASQ Certification and training


+ This position can be located in Raynham, MA, Raritan, NJ or West Chester, PA and requires up to 25% travel.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location

United States-Massachusetts-Raynham-325 Paramount Drive

Other Locations

North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-West Chester


Medical Device Business Services, Inc (6029)

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