Position Summary

The Supplier Quality Specialist is responsible for managing, evaluating, and monitoring supplier quality performance within a regulated Class III medical device environment in compliance with ISO 13485, EU MDR 2017/745, FDA 21 CFR Part 820/QMSR, and internal quality system requirements.

This role plays a critical part in supplier qualification, supplier audits, nonconformance management, CAPA activities, supplier change control, and continuous improvement initiatives to ensure product safety, compliance, and reliability.

Responsabilities

Supplier Management

• Qualify, approve, and maintain critical and strategic suppliers.

• Conduct supplier risk assessments in accordance with ISO 14971 requirements.

• Support supplier selection activities in collaboration with Purchasing, Operations, Manufacturing, and R&D teams.

• Conduct periodic supplier performance reviews and escalation activities when necessary.

Supplier Audits

• Plan and perform supplier quality audits (onsite and remote).

• Assess supplier compliance with ISO 13485, ISOand applicable regulatory requirements.

• Prepare audit reports and ensure timely follow-up of corrective actions.

• Support external audits, notified body inspections, and regulatory inspections.

Nonconformance and CAPA Management

• Investigate supplier-related nonconformances and quality issues.

• Lead root cause investigations using structured problem-solving methodologies.

• Drive supplier corrective and preventive actions (SCAR/CAPA).

• Verify implementation and effectiveness of corrective actions.

Change Management

• Review and assess supplier changes related to processes, materials, equipment, manufacturing sites, or subcontractors.

• Participate in change impact assessments from quality and regulatory perspectives.

• Ensure supplier changes are implemented in compliance with internal procedures and regulatory requirements.

Documentation and Compliance

• Maintain supplier quality documentation including: Approved Supplier List (ASL), Supplier Quality Agreements, Audit reports, Supplier files, and SCAR/CAPA records.

• Ensure documentation complies with ISO 13485 and FDA requirements.

• Support technical documentation and regulatory submissions as needed.

Qualifications & Experience

• Bachelor’s degree in Biomedical Engineering, Operations Engineering, Quality Engineering, or another related technical discipline.

• Minimum of 3 years of experience in Supplier Quality.

• Experience in implantable and/or sterile medical devices.

Knowledge & Skills

• ISO 13485

• ISO 14971

• FDA 21 CFR Part 820 / QMSR

• EU MDR 2017/745

• Bilingual in French and English. The role requires communication with colleagues, suppliers, and clients internationally.

• Strong analytical and problem-solving skills

• Excellent communication and supplier relationship management abilities

• Strong attention to detail and documentation practices

• Ability to work effectively in cross-functional teams

• Strong organizational and prioritization skills

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.