Quality Assurance Specialist
7 days ago
Fluid Biomed Inc. is an innovative medical device startup focused on developing cutting-edge neurovascular stents to treat brain aneurysms and enhance patient outcomes worldwide.
We are seeking a highly skilled Quality Assurance Specialist to join our talented team in Calgary, AB.
The successful candidate will be responsible for leading product quality inspection activities, ensuring compliance with ISO 9001/13485 standards, and collaborating cross-functionally in a fast-paced and dynamic environment.
Key Responsibilities include:
- Leading routine product (stent and delivery components) visual and dimensional inspection activities across incoming materials, in-process sub-assemblies, and finished products, and ensuring they meet quality standards and specifications.
- Determining appropriate inspection sampling plans for batch inspections, as per defined procedures.
- Conducting tests (destructive and non-destructive) to verify product functionality and performance.
- Utilizing measurement tools and equipment (such as digital microscopes, calipers, gauges, etc.,) in aiding the inspection and testing activities.
- Performing equipment verification, as needed, prior to performing inspection and testing activities.
- Developing and maintaining accurate inspection records following Good Documentation Practices (GDP).
- Assisting in improving the product inspection activities, including the development of standard inspection reports, and communicating with internal and external stakeholders.
- Collaborating with the team in raising non-conformance reports (NCRs) related to inspection failures.
- Identifying inspected products with appropriate accepted, rejected, or WIP labels.
- Participating in the in-process and final device manufacturing and assembly activities, including cleaning, packaging, and preparation of sterilization loads.
- Assisting the Engineering team in inspecting prototype materials and/or products.
- Assisting the Engineering team in equipment management activities.
- Providing feedback and recommendations to manufacturing, and inspection processes to improve quality.
- FOLLOWING established safety protocols and guidelines to maintain a safe working environment.
- Participating and supporting in the internal and external audit processes as needed.
- Other quality assurance support activities as required.
Education and Experience Requirements:
- Minimum 2 years of experience as a Quality Inspector in an ISO 9001/13485 industry required.
- Proficiency working with inspection tools, and equipment such as digital microscope, calipers, gauges, etc.
- Ability to inspect products with attention to details, for longer periods of time on a daily basis.
- Ability to work independently and collaboratively in a fast-paced startup environment.
- Effective communication skills for interacting with multidisciplinary teams.
- Ability to operate a laptop and competence with MS Office suite software.
Estimated Salary: $65,000 - $80,000 per year.
Benefits include:
- Competitive salary range.
- Comprehensive benefits package.
- Opportunities for professional growth and development.
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