Director of Quality

Puzzle Medical Devices; Montreal (administrative region); On-site; CAD 150,000 - 210,000; Full time

Benefits offered by this job

Comprehensive group benefits including

Virtual healthcare access

3 weeks vacation + holiday closure

Gym membership reimbursement 50%

Employee referral bonus

Team activities and social events

Free coffee

Job summary

Puzzle Medical Devices is seeking a Director of Quality to provide strategic leadership for the Quality function across the product lifecycle. You will oversee QMS, QA, QC, and risk management while ensuring regulatory compliance and patient safety.

Close collaboration with cross‑functional teams will drive continuous improvement and growth. The role requires a decade of quality leadership in medical devices, deep regulatory knowledge (ISO 13485, MDSAP, FDA QMSR), and a pragmatic, risk‑based

Qualifications

• Bachelor’s degree in Engineering, Science, Life Sciences or related field.
• Minimum 10 years of progressive Quality experience in medical devices or regulated healthcare.
• Experience overseeing and improving a medical device QMS.
• Experience across product lifecycle: development, design transfer, manufacturing, commercialization.
• CAPA, supplier quality, risk management, process validation, audits and regulatory inspections.

Responsibilities

• Lead Quality strategy, objectives, priorities and KPIs.
• Oversee QA/QC functions including incoming inspection and metrology.
• Ensure QMS effectiveness, compliance and continuous improvement.
• Provide oversight of CAPA, nonconformances, complaints, change control, design controls.
• Lead Quality across product development, design transfer and manufacturing.
• Provide quality oversight of product/process quality, risks and trends.
• Represent Quality in regulatory inspections, audits and external matters.
• Lead Management Review with executive visibility on performance and risks.
• Partner with leadership to integrate Quality/regulatory into decisions.
• Build and develop the Quality team and promote a culture of safety.

Skills

Leadership

Regulatory compliance

Quality management

Cross-functional collaboration

Risk management

Education

Bachelor’s degree in Engineering/Science/Life Sciences

Advanced degree is an asset

Tools

ISO 13485

MDSAP

FDA QMSR

IEC 62304

Job description

Join the Team!

Joining Puzzle Medical means becoming part of a team dedicated to improving the treatment of advanced heart failure. You’ll contribute to the development of innovative technology designed to enhance patients’ quality of life and clinical outcomes.

We offer a collaborative and dynamic MedTech environment where initiative is encouraged and ideas are valued. As a growing company, your work will have real impact and visibility, and you’ll have the opportunity to grow alongside the organization.

If you’re motivated by meaningful work and enjoy working in a hands‑on, innovative setting, Puzzle Medical offers the opportunity to contribute to important advancements in patient care.

Summary

The Director of Quality provides strategic leadership and oversight of the company’s Quality function. The Director is accountable for the effectiveness and continuous improvement of the Quality Management System (QMS), Quality Assurance and Quality Control operations, product and process quality, regulatory compliance, and quality risk management.

Working closely with cross‑functional teams, the Director ensures Quality is integrated throughout the product lifecycle, from development and design transfer through manufacturing, while supporting the company’s continued growth and commitment to patient safety.

Responsabilities

• Lead the company’s Quality strategy, objectives, priorities, and performance indicators.
• Oversee the Quality Assurance and Quality Control functions, including incoming inspection, manufacturing QC, and metrology, and software quality assurance.
• Ensure the effectiveness, compliance, and continuous improvement of the Quality Management System (QMS).
• Provide strategic oversight of key Quality processes, including CAPA, nonconformances, complaints, change control, design controls, risk management, supplier quality, and process validation.
• Provide Quality leadership across product development, design transfer, manufacturing
• Ensure appropriate product and process quality oversight, including quality performance, trends, and emerging risks.
• Serve as the senior Quality representative for regulatory inspections, certification audits, and external Quality matters.
• Lead Management Review and provide executive leadership with visibility into Quality performance, compliance, and key risks.
• Partner with cross‑functional leadership to ensure Quality and regulatory requirements are integrated into business and operational decisions.
• Build and develop the Quality team and promote a culture of quality, accountability, continuous improvement, and patient safety.

Qualification & Experience

• Bachelor’s degree in Engineering, Science, Life Sciences, or a related field; advanced degree is an asset.
• Minimum 10 years of progressive Quality experience in the medical device or regulated healthcare industry, including leadership experience.
• Demonstrated experience overseeing and improving a medical device QMS.
• Experience across the medical device product lifecycle, including development, design transfer, manufacturing, and commercialization.
• Experience with CAPA, supplier quality, risk management, process validation, audits, and regulatory inspections.
• Proven ability to lead and influence cross‑functional teams in a growing MedTech environment.

Knowledge & Skills

• Strong knowledge of ISO 13485 and medical device Quality Management Systems.
• Strong knowledge of MDSAP, Health Canada, and FDA requirements, including FDA QMSR.
• Knowledge of ISO 14971 and medical device risk management principles.
• Knowledge of IEC 62304 and medical device software lifecycle requirements.
• Strong understanding of design controls, supplier quality, process validation, and post‑market quality requirements.
• Knowledge of EU MDR (2017/745) and international medical device regulatory requirements.
• Strong leadership and influencing skills across functions and organizational levels.
• Strong analytical, problem‑solving, and risk‑based decision‑making skills.
• Excellent communication and cross‑functional collaboration skills.
• Strong organizational and prioritization skills in a fast‑paced MedTech environment.
• Pragmatic, risk‑based approach to Quality that supports patient safety, regulatory compliance, operational effectiveness, and business objectives.

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.