Why 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.

Position Summary

Puzzle Medical Devices® Inc. is currently seeking a Quality Specialist to support the development, manufacturing, and validation of our percutaneous heart pump system. This role is critical to ensuring that products, processes, and suppliers meet internal quality standards and applicable regulatory requirements.

The ideal candidate is detail-oriented, structured, and proactive, with experience in supplier quality, production documentation, software validation, and quality system compliance in a regulated environment (medical devices preferred).

Responsibilities

Supplier & Production Quality

• Qualify, monitor, and manage suppliers in compliance with internal quality standards and regulatory requirements;

• Review and approve supplier documentation, certifications, and change notifications;

• Support supplier audits, nonconformances, CAPAs, and quality investigations;

• Review and approve job travelers, work instructions, manufacturing forms and records to ensure accuracy, control, traceability and QMS compliance;

• Support document control and change management activities.

Software Validation & Quality Systems

• Plan, execute, and document software and system validation activities (e.g., manufacturing software, test equipment, quality systems);

• Ensure validation activities comply with ISO 13485 and internal procedures;

• Maintain validation documentation, traceability, and revalidation assessments;

• Support internal audits, regulatory inspections, and quality reviews.

Quality Management System (QMS) Maintenance & Improvement

• Maintain and continuously improve the Quality Management System (QMS) in accordance with ISO 13485 and internal procedures;

• Support updates to quality system documentation, including procedures, forms, and templates.

Cross-Functional Collaboration

• Work closely with R&D, manufacturing, operations, procurement, and regulatory teams;

• Provide quality guidance throughout the product development and manufacturing lifecycle.

Qualifications

• Bachelor’s degree (Mechanical, Biomedical, Industrial, or related field);

• Experience in a regulated environment (medical devices strongly preferred);

• Experience with supplier quality, production documentation, and change control;

• Experience supporting manufacturing of implantable or Class II/III medical devices (asset);

• Experience with audits (internal, supplier, or regulatory) (asset).

Knowledge and skills

• Knowledge of quality standards and regulations such as ISO 13485, FDA QMSR, and GxP principles;

• Familiarity with software validation principles and documentation;

• Strong attention to detail, organizational skills, and analytical mindset;

• Ability to communicate clearly and work effectively in a cross-functional, fast-paced environment;

• Familiarity with electronic QMS tools (asset);

• Advanced proficiency in technical writing and strong reading comprehension in both French and English. The role requires communication with colleagues, suppliers, and clients internationally.

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.