Quality Control Specialist
Puzzle Medical Devices
Quality Assurance
Montreal, QC, Canada
Position Summary
The Quality Control Specialist is responsible for reviewing and ensuring the completeness, accuracy, and compliance of manufacturing and quality documentation throughout the entire product lifecycle — from incoming inspection to final lot release.
This role plays a key part in maintaining product quality and regulatory compliance by reviewing Job Travelers, Device History Records (DHRs), inspection records, manufacturing documentation, metrology reports, machine shop documentation, and cleanroom records.
The ideal candidate is highly detail-oriented, rigorous, organized, and comfortable working in a fast-paced, cross-functional environment. Experience in highly regulated or precision-driven industries such as medical devices, automotive, aerospace, or aeronautics is highly valued.
Responsabilities
Documentation Review & Batch Record Review
Review and approve manufacturing documentation including:
Job Travelers
Device History Records (DHRs)
Incoming inspection records
Manufacturing records
Metrology reports
Machine shop documentation
Cleanroom documentation
Final lot release documentation
Ensure documentation is complete, accurate, traceable, and compliant with internal procedures and regulatory requirements.
Verify that all manufacturing and inspection steps have been properly executed and documented.
Quality Control Activities
Support incoming inspection and in-process quality control activities.
Review nonconformances, deviations, and discrepancies identified during manufacturing.
Escalate quality issues and documentation gaps when necessary.
Ensure proper implementation of corrective actions before lot release.
Lot Release Support
Support final product release activities by ensuring all required quality documentation is complete and approved.
Verify compliance with specifications, procedures, and acceptance criteria prior to release.
Collaborate with Manufacturing teams to resolve documentation issues efficiently.
Cross-Functional Collaboration
Work closely with: Manufacturing, Metrology, Machine Shop, Cleanroom Operations, Supply Chain, and Engineering teams
Participate in continuous improvement initiatives related to documentation quality and manufacturing processes.
Qualification & Experience
Bachelor’s degree or technical diploma in Engineering, Quality, Manufacturing, Industrial Technology, or related field.
Minimum 3 years of experience in Quality Control, Manufacturing Quality, or Documentation Review.
Experience in regulated or high-precision industries such as: Medical Devices, Automotive, Aerospace, Aeronautics
Experience reviewing manufacturing documentation and batch records is strongly preferred.
Knowledge & Skills
Understanding of manufacturing and inspection processes.
Familiarity with: Device History Records (DHR), Job Travelers, Traceability requirements, Quality documentation systems
Knowledge of quality standards and regulated environments is considered an asset: ISO 13485, AS9100, ISO 9001 IATF 16949, GMP principles.
Knowledge of inspection tools, calibration, and metrology documentation.
Bilingual in French and English. The role requires communication with colleagues, suppliers, and clients internationally.
Exceptional attention to detail
High level of rigor, accuracy, and accountability
Confidence and assertiveness to proactively follow up with cross-functional teams to ensure records are properly completed and compliant
Strong communication and interpersonal skills
Comfortable working in a fast-paced, cross-functional environment
Ability to manage multiple priorities effectively
Problem-solving mindset with a proactive attitude
At Puzzle, we value our employees and offer a comprehensive benefits package
Comprehensive group benefits including medical, dental, and vision coverage;
Virtual healthcare access for you and your immediate family (Dialogue)
2 sick days + 3 personal days to support your work-life balance;
50% reimbursement on gym memberships to support your well-being;
3 weeks of vacation + Paid holiday closure in December so you can fully enjoy the festive season;
Employee referral bonus program;
Free coffee to keep you energized;
Regular team activities and social events to foster a collaborative and fun work environment.