Staff Quality Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About MedTech

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for a Staff Quality Engineer to be located at Markham Ontario Canada.

The Staff Quality Engineer provides independent quality oversight for drug and medical device products marketed in Canada ensuring compliance with Health Canada regulations including Health Canada Food and Drugs Act GUI0001 (GMP for drug products) and Medical Devices Regulations (SOR/98-282).

This role serves as the designated technical responsible person for drug product quality within the marketing company supporting compliance with Drug Establishment License (DEL) expectations and ensuring that quality systems processes and product lifecycle activities meet regulatory and corporate standards.

The position has direct accountability for maintaining inspection readiness and hosting Health Canada audits and inspections acting as a primary quality representative for regulatory authorities.

The role partners cross-functionally with Marketing Sales Supply Chain Regulatory Affairs Post Market Safety and Global Franchise Quality to ensure compliant product commercialization and lifecycle management.

The role reports to the Commercial Quality Senior Manager and operates with high individual ownership and decision-making authority without formal people management responsibility.

Key responsibilities:

• Quality System Oversight

  • Leads and supports the implementation and maintenance of Quality Management Systems (QMS) in alignment with corporate standards and Canadian regulatory requirements for Drugs and Medical Devices.

  • Initiates investigates reviews and approves quality records including NCs deviations CAPAs change controls and validation documentation.

  • Ensures procedures exist for recording evaluating investigating and trending quality events and system performance.

  • Maintains audit-ready documentation and ensures completeness and traceability of GMP records.

• Audit & Inspection Management

  • Serves as primary host/front room lead for external inspections including Health Canada audits for drug and medical device products.

  • Coordinates and leads preparation activities for regulatory inspections including SME alignment documentation readiness and response planning. Supports internal audits supplier audits and third-party audits as required. Owns and tracks regulatory commitments and responses to inspection observations.

• Regulatory & Technical Accountability (Health Canada GUI0001)

  • Acts as the technical quality representative for drug products ensuring compliance with Health Canada GMP requirements (GUI0001) across marketing distribution storage and lifecycle activities.

  • Ensures quality systems support GMP elements including CAPA deviations complaints validation training and documentation control.

  • Maintains oversight of product quality attributes (identity strength purity safety quality) throughout the commercial lifecycle.

  • Supports compliance with Drug Establishment License (DEL) requirements and applicable sections of the Food and Drug Regulations.

• Marketing Company Quality Oversight Support

  • Ensures and implements commercial compliant handling storage transport and distribution practices for drug and device products meet applicable internal standards and external regulations for drug and devices.

  • Provides Quality oversight support for marketing company operations ensuring adherence to defined regulatory requirements procedures storage and transport conditions.

  • Leads and ensures appropriate controls for product release disposition and traceability where applicable.

• Cross-Functional Collaboration

  • Partners with Marketing Sales Regulatory Affairs Supply Chain Medical Affairs and Global Post Market Safety to ensure regulatory compliance and product quality.

  • Acts as Quality SME for Canada Marketing company operations supporting projects issue resolution investigations and risk mitigation.

  • Participates in management reviews and supports reporting of quality system effectiveness.

• Continuous Improvement & Compliance

  • Drives continuous improvement initiatives to enhance QMS effectiveness and regulatory compliance.

  • Identifies risks and implements mitigation plans aligned with GxP expectations.

  • Ensures sustained inspection readiness through ongoing monitoring and governance.

  • Leads continuous improvement projects as applicable.

Qualifications

Required:

• Minimum of a Bachelors 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 GUI0001)

• 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

Preferred:

• Marketing distribution storage and lifecycle quality oversight requirements

• Experience with copy approval process controls and governance

• Experience with software: SAP EtQ Agile

• Certified/qualified lead auditor

Other:

• This position may require up to 1020% domestic and/or international travel.

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The anticipated base pay range for this position is :

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