Quality Control Technician

Puzzle Medical Devices® Inc. develops a minimally invasive cardiac pump intended for patients with advanced heart failure. The device design allows for minimally invasive implantation to support both renal and cardiac functions through a 4 mm pump implanted in the descending aorta with a 4 Fr axillary training line, enabling full patient mobility.

Puzzle Medical Devices is seeking a Quality Control Technician to join its team. The QC Technician performs in-process and final inspections of implantable medical devices in ISO-classified cleanroom environments to ensure compliance with specifications and regulatory requirements. They also review device history records (DHR) to ensure accuracy and compliance with documentation best practices, and ensure adequate documentation of non-conformities and corrective actions.

In-Process Quality Control

• Perform in-process inspections in ISO-classified cleanroom environments.
• Verify compliance with approved manufacturing instructions, work instructions, and device master records (DMR).
• Conduct dimensional, visual, and functional inspections using calibrated measurement equipment.
• Monitor critical process parameters and document inspection results.

Final Product Inspection

• Perform final inspections of implantable medical devices before product release.
• Verify labeling, packaging integrity, product traceability, and identification.
• Ensure all acceptance criteria are met according to product specifications.

Documentation Review

• Review device history records (DHR) to verify completeness and accuracy.
• Verify that manufacturing documentation complies with documentation best practices (GDP).
• Ensure that deviations, non-conformities, and corrective actions are properly documented.

Education and Experience

• Bachelor's degree in engineering (mechanical, biomedical, or related field).
• 3 to 5 years of experience in quality control in the medical devices, automotive, aerospace, or aeronautical sectors.
• Experience with Class III implantable medical devices (an asset).

Knowledge and Skills

• Knowledge of complex manufacturing processes.
• Knowledge of quality inspection techniques, including visual, dimensional, and functional inspections.
• Understanding of ISO 13485 standard (an asset) and documentation best practices (GDP).
• Familiarity with a controlled production environment.
• Advanced English level. The person occupying this role will need to communicate with external partners located outside Quebec.
• Strong attention to detail and ability to detect defects or non-conformities.
• 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 precision.
• At Puzzle, we value our employees and offer a comprehensive benefits program
• Comprehensive health benefits including medical, dental, and vision insurance.
• Access to telemedicine services for you and your immediate family (Dialogue).
• 2 sick days and 3 personal days to promote work-life balance.
• 50% reimbursement of gym membership fees.
• 3 weeks of vacation + office closure during the December holidays (paid).
• Employee referral bonus program.
• Free coffee to keep you energized.
• Salary: Starting at $1,000 per year

Benefits

• Dental Insurance
• Supplementary Health Insurance
• Life Insurance
• Vision Insurance
• On-site Gym
• Flexible arrival and departure times
• Stock Purchase Options
• RVER
• On-site Parking
• Casual Dress Code
• Location: On-site