Medical Device Quality Assurance Specialist
2 weeks ago
We are seeking a highly motivated and detail-oriented individual for the role of Medical Device Quality Assurance Specialist at Fluid Biomed Inc. in Calgary, AB.
About Us
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.
Job Description
- Lead routine product (stent and delivery components) visual and dimensional inspection activities across incoming materials, in-process sub-assemblies, and finished products, and ensure they meet quality standards and specifications.
- Determine appropriate inspection sampling plan for batch inspections, as per defined procedures.
- Conduct tests (destructive and non-destructive) to verify product functionality and performance.
- Utilize measurement tools and equipment (such as digital microscopes, calipers, gauges, etc.,) in aiding the inspection and testing activities.
- Perform equipment verification, as needed, prior to performing inspection and testing activities.
- Develop and maintain accurate inspection records following Good Documentation Practices (GDP).
- Assist in improving the product inspection activities, including the development of standard inspection reports, and communicating with internal and external stakeholders.
- Collaborate with the team in raising non-conformance reports (NCRs) related to inspection failures.
- Identify inspected products with appropriate accepted, rejected, or WIP labels.
- Participate in the in-process and final device manufacturing and assembly activities, including cleaning, packaging, and preparation of sterilization loads.
- Assists the Engineering team in inspecting prototype materials and/or products.
- Assist the Engineering team in equipment management activities.
- Provide feedback and recommendations to manufacturing, and inspection processes to improve quality.
- Follow established safety protocols and guidelines to maintain a safe working environment.
- Participate and support in the internal and external audit processes as needed.
- Other quality assurance support activities as required.
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, calippers, 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.
Benefits
- Estimated salary: $80,000 - $110,000 per year, depending on experience.
- Opportunity to work with a cutting-edge medical device company.
- Collaborative and dynamic work environment.
- Professional growth and development opportunities.
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