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Quality Control Specialist

Montreal, Quebec, Canada
Mid Level
Full-Time

About the role

The company Our client are a medical device company specialising in the design and manufacturing of implantable technologies. The team operates within ISO-classified cleanroom environments, applying rigorous quality and regulatory standards to bring life-changing devices to patients safely and reliably.

The opportunity Offering an excellent opportunity for a detail-oriented Quality Control Specialist to join their Quality department. They are looking for a QC professional with hands-on inspection experience, ideally within medical devices or another highly regulated manufacturing environment.

In this role, you will perform in-process and final inspections of implantable medical devices within ISO-classified cleanroom environments, ensuring compliance with specifications and regulatory requirements. You will also review manufacturing records to verify accuracy and documentation integrity, playing a direct role in patient safety and product quality.

Day to day, you will 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 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 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

Professionally, you will have A Bachelor's degree in Engineering (Mechanical, Biomedical, or a related field) 3–5 years of Quality Control experience in Medical Devices, Automotive, Aerospace, or Aeronautics Experience with Class III implantable medical devices (an asset) Knowledge of complex manufacturing processes and 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 Strong attention to detail and the ability to identify defects or nonconformities Excellent organisational skills with the ability to maintain accurate and complete records Ability to follow detailed procedures and work instructions with a high degree of precision

Personally, you Communicate quality issues clearly and effectively across cross-functional teams Collaborate well with others in a regulated manufacturing environment Take ownership of your work and hold yourself to a high standard of accuracy and consistency Demonstrate a high level of integrity and a genuine commitment to product quality and patient safety Thrive in a structured, detail-driven environment where precision matters

About Hlx Life Sciences

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