Supervisor, QualityCompliance

DePuy Synthes isrecruiting foraSupervisor Quality/Compliance.This Hybrid position will be located in Raynham MA (USA). Alternate Hybrid locations maybe considered at Raritan NJ (USA); West Chester PA (USA); Palm Beach Gardens FL (USA).

Johnson & Johnson announced plans to separate our Orthopedics business toestablisha standalone orthopedics companyoperatingas DePuy Synthes. The process of the planned separation isanticipatedto be completed within 18 to24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be regulatory approvals and other customary conditions and approvals. Should you accept this position it isanticipatedthat following conclusion of the transaction you would be an employee of DePuySynthesand your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes atan appropriate timeand subject to any necessary consultation processes.

Job Overview

The Supervisor Quality/Compliance plays a critical leadership role in ensuring that DePuy Synthes products processes and systems meet internal quality standards and external regulatory requirements. This role leads daytoday quality and compliance activities supports audits and inspections and partners closely with Manufacturing Engineering and Regulatory teams to drive a culture of compliance and continuous improvement. The position offers the opportunity to directlyimpactpatient safety product quality and regulatory readiness at a highvisibility manufacturing site.

Key Responsibilities

• Supervise and support a team of Quality and/or Compliance professionals ensuring effective execution of quality system processes.

• Ensure compliance with applicable regulations and standards (e.g. FDA QSR ISO 13485 and internal quality policies).

• Lead and support internal and external audits regulatory inspections and customer audits including preparation execution and followup.

• Oversee investigation and resolution of nonconformances deviations CAPAs and complaints ensuringtimelyand compliant closure.

• Review and approve quality documentation such as SOPs work instructions protocols and reports.

• Partner crossfunctionally to assess and mitigate quality and compliance risks related to manufacturing suppliers and product changes.

• Drive continuous improvement initiatives to enhance quality system effectiveness and operational performance.

• Coach develop and evaluate team members to build technical capability and leadership readiness.

Qualifications

Education

• Required:Bachelors degree in Engineering Life Sciences Quality ora relatedtechnical discipline.

• Preferred: Advanced degree (MS or equivalent) in a related field.

Experience and Skills

Required:

• 46 years of experience in Quality Compliance or Regulatory roles within a regulated industry (medical device preferred).

• Prior experience leading or supervising employees or project teams.

• Strong working knowledge of quality management systems and regulatory requirements.

• Experience with audits inspections and quality investigations (CAPA deviations nonconformances).

Preferred:

• Experience supporting manufacturing operations in a medical device environment.

• Familiarity with risk management tools and continuous improvement methodologies (e.g. Lean Six Sigma).

• Experience interacting directly with regulatory agencies or notified bodies.

• Strong written and verbal communication skills with the ability to influence crossfunctional partners.

Other

• Language: English (required).

• Travel: Up to 10% (domestic) as needed.

• Certifications (Preferred): ASQ certifications (CQE CQA) Lean or Six Sigmacertification.

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 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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