Staff Quality Engineer
$90,300–$140,300 year
On-site · Markham, Ontario, Canada
Job Summary
Staff Quality Engineer at Johnson & Johnson oversees quality systems and regulatory compliance for drug and medical device products marketed in Canada. Responsibilities include quality system oversight, handling CAPAs, deviations, change controls, validation, and maintaining audit-ready documentation; hosting Health Canada inspections and coordinating regulatory responses; acting as technical quality authority for drug products under Health Canada GMP requirements (GUI-0001); ensuring lifecycle quality across marketing, distribution, storage, and lifecycle activities, and collaborating cross-functionally with Marketing, Sales, Regulatory Affairs, Supply Chain, Post Market Safety, and Global Franchise Quality to support compliant product commercialization.
Required Qualifications
- Minimum of a Bachelor’s Degree in Science, Engineering, or related discipline
- A minimum of 4 years of experience in a Quality or Regulatory role within a GMP-regulated environment (pharmaceutical, medical device, or combination products)
- Experience with Health Canada regulations, including Health Canada Food and Drugs Act, Medical Devices (SOR/98-282)and Drug regulations(Health Canada GUI‐0001)
- Experience supporting or hosting regulatory inspections
- Quality Systems (CAPA, deviations, change control, validation)
- Demonstrated ability to operate independently as a technical quality authority
- Strong communication skills with the ability to interface directly with regulatory agencies
- Proven problem-solving, risk assessment, and decision-making capabilities
- Ability to manage multiple priorities and maintain inspection readiness
- Travel up to 10–20% (domestic and/or international)
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