Supervisor, Quality/Compliance

Johnson & Johnson Innovative Medicine • West Chester, PA

1d • Hybrid

About The Position

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 day‑to‑day 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 directly impact patient safety, product quality, and regulatory readiness at a high‑visibility manufacturing site.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical discipline.
• 4–6 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).
• English (required).

Nice To Haves

• Advanced degree (MS or equivalent) in a related field.
• 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 cross‑functional partners.
• ASQ certifications (CQE, CQA), Lean or Six Sigma certification.

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 follow‑up.
• Oversee investigation and resolution of nonconformances, deviations, CAPAs, and complaints, ensuring timely and compliant closure.
• Review and approve quality documentation such as SOPs, work instructions, protocols, and reports.
• Partner cross‑functionally 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.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level