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Senior Quality Engineer.

Company: Johnson & Johnson
Location: Raynham
Posted on: January 12, 2022

Job Description:

DePuy Synthes, a member of the Johnson & Johnson family of companies, is currently recruiting for a Senior Quality Engineer, located in Raynham, MA.

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

Position Summary

The Senior Quality Engineer - Projects strategizes and partners multi-functionally to conduct and document engineering projects related to design transfer activities of new product introductions, process and equipment verifications/validations related to capacity enhancements, and technology/process improvements to drive process efficiencies and mistake-proofing. To do so successfully, they apply comprehensive and diverse knowledge of engineering and quality engineering principles and practices as well as problem solving and risk management skills. This person will also support the quality engineering activities of day-to-day manufacturing when appropriate and applicable.

Key Responsibilities

  • Strategizes validation and verification approaches for projects and provides project planning/management support
  • Delivers and/or provides timely reviews/approval of validation/verification documentation, quality records (NR, CAPA IP/AP/EM, Audit AP/EM), and risk documentation
  • Develops and executes project related activities, not limited to, test method validation protocols, manufacturing control plans, process monitoring and control methods, and sampling plans
  • Partners multi-functionally to ensure the proper application and documentation of design controls, risk management, and the investigation/correction of design and process failures/challenges
  • Serves as site support for all internal and external regulatory and compliance audits
  • Champions multi-functional communication and team work and promotes proactive quality in actions and behaviors

    Required

    Qualifications
    • A minimum of a bachelor's degree in Biomedical/Mechanical Engineering or related technical field is required.
    • A minimum of 5 years of related experience is required.
    • Experience working in both an FDA and European regulatory environment in manufacturing/operations are required.
    • Experience with IQ, OQ, PQ (Process Validation), TMV, Process Verification, Software Validation is required.
    • In-depth knowledge of product/process Risk Management (FDA and ISO standards) and a proven track record of implementing appropriate risk mitigation is required.
    • Technical training and experience using Statistics (ANOVA, Capability, sampling plan justifications), Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc is required.
    • Solid understanding of statistical software packages (ie: Minitab, .jmp) with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making is required.
    • The ability to perform "hands on" troubleshooting and problem solving is required.
    • Proven project management and project leadership abilities are required in addition to strong communication and interpersonal skills.
    • This position may require up to 10% travel and will be based in the Raynham, MA, DePuy Synthes Orthopedics manufacturing facility.
    • Fluent in English (both oral and written) is required.

      Preferred
        • Experience with Geometric Dimensioning & Tolerancing (GD&T) and interpretation of engineering drawings is desired.
        • Understanding of design control, the NPI (New Product Introduction) process, and Process Validation expertise.
        • The ability to think on one's feet and provide sound judgment.
        • A thorough understanding of GMP/ISO regulations and validation regulations.
        • Good technical understanding of manufacturing equipment and processes.

          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

          Organization

          Medical Device Business Services, Inc (6029)

          Job Function

          Engineering

          Requisition ID

          2105961467W

Keywords: Johnson & Johnson, Brockton , Senior Quality Engineer., Engineering , Raynham, Massachusetts

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