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Quality Assurance Technician
3 weeks ago
Under the supervision of the Quality Manager, the Quality Assurance Technician is responsible for ensuring product compliance with the quality assurance and control procedures established by Cryopak. They will actively participate in the research and development of new products as well as the corrective action process.
Responsibilities
- Maintain the quality system up to date
- Organize and manage the calibration of measuring instruments (scales and calipers)
- Write and update internal and external specifications for finished products.
- Document identified non-conformities and ensure follow-up
- Train or raise staff awareness on good practices (BPF/GMP, GDP, etc.).
- Actively participate in the problem analysis process (CAPA) related to non-conformities (internal or customer complaints).
- Administer and control the required certifications for raw materials and provide all compliance documentation to our clients (CofC, CofA, others...).
- Manage non-conforming products (identification, quarantine, and communication)
- Review and approve inspection sheets from quality inspectors
- Verify and approve change requests related to the specifications of finished products.
- Support R&D teams during testing or when launching a new product
- Actively participate in the creation of new items
- Participate in internal audits, client audits, and regulatory inspections.
- Contribute to the continuous improvement of processes (5S, CAPA, etc.).
- Maintain close collaboration with the Quality Manager in their involvement with external audits, quality contracts signed with certain clients, and various official regulations (FDA/Health Canada, etc.)
- Train and supervise quality inspectors.
- Any other related tasks
Minimum Education
DEC or Certificate in Management and Quality Assurance with 2 years of experience in quality.
Experience
2 to 3 years
Other Required Skills
Very good knowledge of the Office suite and ERP system.
Fluent in French and advanced level in English. Due to the nature of this role, approximately 75% of tasks involve collaboration with colleagues and clients in the USA and Western Canada. This includes participating in meetings with US and Western Canada clients, conducting audits in English, and preparing reports in English. Proficiency in English is essential to ensure clear communication, accurate documentation, and effective collaboration with our international partners.
Knowledge of medical device regulations from Health Canada & FDA (assets)
Knowledge of quality standards (e.g., ISO 9001, BPF/GMP).
Knowledge of quality tools and methods (5 Whys, Ishikawa).
Good analytical and synthesis skills
Exhibits organization with strong time management skills
A good team spirit with a high level of interpersonal relationships
Ability to work with minimal supervision, sense of organization, and autonomy
Knowledge of quality control principles and sampling plans.
Why Work For Us
6 sick days
Group insurance premium paid at 70%
RRSP and DPSP employer match to 3%
parking on site
social activities
vacation above the employment standards
