This is a unique opportunity to join an early-stage company to advance the development of a novel implantable medical device, ensuring its readiness for human use. Fluid Biomed is an innovative medical device startup focused on developing a cutting-edge neurovascular stent to treat brain aneurysms and enhance patient outcomes worldwide. We are seeking a highly flexible and motivated person for the role of Quality Inspector to join our talented team. Reporting to the Quality Specialist, the Quality Inspector will lead the product quality inspection activities, and provide support in the manufacturing, assembly, cleaning, and packaging activities. The role will work within the Quality Department in a fast paced and dynamic environment where attention to detail, ability to multi-task, and collaborating cross-functionally are critical for success.

Key Responsibilities include:

• 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.

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.

Additional Skills:

• Associate degree or equivalent preferred.
• Excellent documentation, organizational, communication (written & oral), and interpersonal relationship skills.
• Knowledge and ability to interpret blueprint reading / technical drawings and GD&T.
• Ability to adhere to Quality Management Systems requirements (ISO 13485).
• Ability to navigate uncertainty/fluidity in role scope, priorities, and timelines.
• Ability to manage competing priorities in a fast-paced and dynamic environment.

Role is on-site in Calgary, AB and candidates must be legally entitled to work full time in Canada.