Puzzle Medical Devices is seeking a Quality Control Specialist to join our team. This QC Specialist performs in-process and final inspections of implantable medical devices within ISO-classified cleanroom environments to ensure compliance with specifications and regulatory requirements. They also review manufacturing records (DHRs) to verify accuracy and adherence to Good Documentation Practices, and ensure that nonconformances and corrective actions are properly documented.

Responsabilities

In-Process Quality Control

• Perform in-process inspections during manufacturing within ISO-classified cleanroom environments.

• Verify compliance with approved manufacturing instructions, work instructions, and Device Master Records (DMRs).

• Conduct dimensional, visual, and functional inspections using calibrated measuring equipment.

• Monitor critical process parameters and document inspection results.

Final Product Inspection

• Perform final inspection of implantable medical devices prior to product release.

• Verify labeling, packaging integrity, traceability, and product identification.

• Ensure all acceptance criteria are met according to product specifications.

Documentation Review

• Review Device History Records (DHRs) for completeness and accuracy.

• Verify that manufacturing documentation complies with Good Documentation Practices (GDP).

• Ensure deviations, nonconformances, and corrective actions are properly documented.

Qualification & Experience

• Bachelor's Degree in Engineering (Mechanical, Biomedical, or related field).

• 3-5 years of Quality Control experience in the Medical Devices, Automotive, Aerospace or Aeronautics industry.

• Experience with Class III implantable medical devices is preferred.

Knowledge & Skills

• Knowledge of complex manufacturing processes.

• Knowledge of quality inspection techniques, including visual, dimensional, and functional inspections.

• Understanding of ISO 13485 (an asset) and Good Documentation Practices (GDP);

• Familiarity with a controlled manufacturing environment.

• Advanced English proficiency. This role requires communicating with external partners located outside of Quebec.

• Strong attention to detail and ability to identify defects or nonconformities.

• Excellent organizational skills with the ability to maintain accurate and complete records.

• Ability to follow detailed procedures and work instructions with a high degree of accuracy.

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.