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J&J Family of Companies Staff Quality Systems Engineer in Raynham, Massachusetts

DePuy Synthes, a Johnson & Johnson company is hiring a Staff Quality Systems Engineer located in Raynham, MA.

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in 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.

Overall Responsibilities

The Staff Quality Systems Engineer oversees and manages the execution of Quality Systems (QS) at site level, including Nonconformances (NC), Corrective and Preventive Action (CAPA), Internal Audit (IA) Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, Quality Progress Review (QPR), Quality System Management Review (QSMR), and other assigned QS activities to ensure systems are effective and in compliance for the Raynham Manufacturing site and Bridgewater Receiving Inspection for Depuy Synthes/ Medical Device and Codman & Shurtleff, Inc. entities with respect to quality systems.. Manages the performance and communication of QS metrics at site level. Ensures site readiness in the deployment of QS initiatives. Supports compliance and document control areas, and continuous improvement of the Quality System.

The Quality Systems Engineer will have following responsibilities:

  • Responsible for the consistent and correct execution of QS procedures at the site to ensure the quality and compliance of processes and records for NC, CAPA, IA Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, QPR and QSMR,

  • Develops competency of resources at the site that execute NC, CAPA, IA Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, QPR and QSMR, by providing training and guidance on the execution and documentation of these processes,

  • Responsible for the timely and compliant execution of site NCs, CAPA, IA Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, QPR and QSMR, by championing cross-collaboration across functions, sites, and operating companies; identifying barriers for the progress; and elevating issues for resolution,

  • Manages on-site QPR and QSMR, including coordination, preparation, execution, and tracking of activities,

  • Manages Product Quality Escalations for nonconformances or issues originating at the site, including the initiation, escalation, coordination, tracking, and closure of activities

  • Manages on site the timely collection, escalation and reporting of all Quality System metrics to management

  • Maintains and reviews documentation for site NC, CAPA, IA Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, QPR and QSMR as quality records,

  • Identifies site needs to meet and improve system performance of NC, CAPA, IA Observation, Site Complaint Manufacturing Investigation, Product Quality Escalation, QPR and QSMR at the site level, and escalates to appropriate representative and management in a timely manner,

  • Collaborates with Franchise Quality in the deployment (design, implementation, and post-monitoring) of QS initiatives impacting the site that promote the continuous improvement of the QS and ensure continuity of the application of globally shared processes and systems at site level,

  • Supports compliance activities by participating in audit readiness; assists in Internal and External audits; serves as Subject Matter Expert for NC, CAPA, IA Observation, Site Complaint Manufacturing Investigation, Product Quality Escalation, Document Control, QPR and QSMR processes during audits; manages the investigation, response, and remediation of site-specific QS audit observations

  • Oversees on site Document Control (as required), including management of change documentation, on-site administration of the change control system, and archival of documents on site

Qualifications

Education & Required Skills/Experiences:

  • A Bachelor’s Degree is required.

  • Minimum of 6 years of experience working in Healthcare, Pharmaceutical, Clinical Research, or Medical Device industry.

  • Minimum of 2 years of experience working in a Quality function (Quality Management, Quality Assurance/Control and/or Compliance).

    Preferred Skills/Experiences:

  • Strong knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP).

  • Bachelor’s or advanced degree in Engineering or related technical field

  • Health Authority Inspection experience (FDA, EMA and other inspectorates).

  • Strong Project Planning/Management skills.

  • Proven ability to analyze & interpret collective data to provide insights to drive decision-making.

  • Experience with medical devices

  • Experience conducting risk management activities

  • Experience in Quality Auditing and notified body inspections

  • Experience with root cause investigation, change management, risk management and technical writing is required.

  • Experience in Quality Systems process development, support, integration or enhancement is preferred.

  • Advanced use of computer and software applications is required. Experience with training or coaching Qualifications

    Other:

  • This position will be based in Raynham, MA and requires up to 10% travel (international and domestic).

    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, candidates offered employment must show proof of COVID-19 vaccination or 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. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

    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

2206021235W

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