Job Function:
Quality
Job Sub Function:
Customer/Commercial Quality
Job Category:
Professional
All Job Posting Locations:
Markham, Ontario, Canada
Job Description:
We 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 Bachelor019s 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:
Required Skills:
Preferred Skills:
Audit Management, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)
The anticipated base pay range for this position is :
$90,300 to $140,300
Additional Description for Pay Transparency:
As applicable for the role - Under current guidelines, this position is eligible for a discretionary performance bonus. The Company uses Artificial Intelligence in its assessment of applicants. This job posting is for an existing position.
