Cq Specialist

Johnson & Johnson Johnson & Johnson · Pharma · Markham, ON +1

Johnson & Johnson is seeking a CQ Specialist in Markham, Ontario, Canada, to support the execution and maintenance of Quality and Compliance activities for DePuy Synthes's orthopedic portfolio. The role ensures products, processes, and systems meet internal requirements and external regulatory standards, partnering cross-functionally to drive compliance and safeguard patient safety. Responsibilities include QMS maintenance, documentation review, audit support, quality event investigation, and continuous improvement initiatives within a regulated medical device environment.

What you'd actually do

  1. Support implementation and ongoing maintenance of Quality Management System (QMS) processes in alignment with global and regional requirements.
  2. Execute and track quality and compliance activities, including documentation review, record management, and metrics reporting.
  3. Participate in internal audits, inspections, and assessments; support preparation, execution, and follow‑up activities.
  4. Support investigation, documentation, and closure of quality events, including deviations, nonconformances, and CAPAs.
  5. Collaborate with cross‑functional partners (Manufacturing, Engineering, Regulatory, Supply Chain) to ensure compliance with applicable standards and procedures.

Skills

Required

  • Quality Management System (QMS)
  • documentation controls
  • CAPA
  • attention to detail
  • standard business systems
  • quality databases

Nice to have

  • audits
  • inspections
  • medical device regulations
  • ISO 13485
  • FDA QSR
  • continuous improvement initiatives
  • orthopedic or implantable medical device operations
  • Quality-related certifications

What the JD emphasized

  • regulated environment
  • quality systems
  • compliance principles