Supervisor, Quality/compliance

Johnson & Johnson Johnson & Johnson · Pharma · Raynham, MA +5

This role is for a Supervisor of Quality/Compliance within Johnson & Johnson's DePuy Synthes business, focusing on ensuring products and processes meet internal quality standards and external regulatory requirements in a medical device manufacturing environment. Responsibilities include leading a team, supporting audits and inspections, overseeing investigations of nonconformances and deviations, and driving continuous improvement. The role requires experience in quality, compliance, or regulatory roles within a regulated industry, with a Bachelor's degree in a related field.

What you'd actually do

  1. Supervise and support a team of Quality and/or Compliance professionals, ensuring effective execution of quality system processes.
  2. Ensure compliance with applicable regulations and standards (e.g., FDA QSR, ISO 13485, and internal quality policies).
  3. Lead and support internal and external audits, regulatory inspections, and customer audits, including preparation, execution, and follow‑up.
  4. Oversee investigation and resolution of nonconformances, deviations, CAPAs, and complaints, ensuring timely and compliant closure.
  5. Review and approve quality documentation such as SOPs, work instructions, protocols, and reports.

Skills

Required

  • 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)

Nice to have

  • 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

What the JD emphasized

  • quality standards
  • regulatory requirements
  • FDA QSR
  • ISO 13485
  • audits
  • inspections
  • nonconformances
  • deviations
  • CAPAs
  • complaints