Quality Specialist

4 weeks ago

Calgary, Canada Fluid Biomed Inc. Full time

This is a unique opportunity to join a 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 Specialist to join our talented team. Reporting to the Quality Engineer, the Quality Specialist will act as management representative in administrating the elements of the Quality Management System (QMS), lead the quality inspection and supplier quality activities, manage overall inventory, training, and calibration programs, and support the Engineering and Operations team. The role will work within the Quality Department in a fast paced and dynamic environment where attention to detail, ability to multi-task, taking initiatives and collaborating cross-functionally are critical for success.


Key Responsibilities include:


  • Own and maintain effective QMS processes and procedures in accordance with ISO 13485 standards
  • Manage company document control activities including revision controls, SOP/document review and approval, document retention and archiving, electronic and hardcopy filing, etc.
  • Maintain Technical documents (Engineering Specifications & Drawings) library
  • Complete receiving documentation for incoming parts, components, or equipment
  • Prepare and lead annual QMS Management Review meetings and present to the team and executives
  • Act as Management Representative in coordinating regulatory compliance activities/audits with external regulatory affair bodies to obtain and maintain necessary ISO certifications and approvals
  • Under ISO 13485 requirements, maintain and execute the internal audit process to assess compliance with QMS requirements and identify areas for improvements
  • Establish and maintain key performance indicators (KPIs) to monitor product quality and process effectiveness
  • Lead and improve product inspection activities, including the development of standard inspection reports, and communicating with internal and external stakeholders
  • Initiate, investigate, and resolve non-conformance reports (NCRs), by implementing corrective and preventive actions (CAPAs) to address root causes of product and process quality issues, and prevent recurrence in a timely manner
  • Own and maintain Approved Supplier List (ASL) including qualification, approval, development of quality agreements, and performance evaluation of suppliers in coordination with Engineering team
  • Assist in the procurement and installation of necessary quality and operational equipment by preparing request for quotes (RFQs), shipping documentation, technical qualification documentation, etc. as required
  • Maintain supplier quality documentation including Certificate of Analysis, inspection reports, etc.
  • Execute Non-Disclosure Agreements (NDAs) for external service providers, as required
  • Manage overall equipment calibration process including maintenance of calibration/maintenance reports, and coordinate ongoing equipment service or testing, in coordination with the Engineering team
  • Manage overall inventory control process including physical and electronic inventory of conforming/non-conforming product, delivery components, and supporting equipment
  • Manage overall training program and maintain training KPI reports, matrix, files, and records for all staff
  • Provide training and education to staff on quality processes, procedures, and regulations as required
  • Lead and support continuous improvement project activities across the organization
  • Support other Quality Department activities as required


Education and Experience Requirements:


  • Bachelor’s degree and a minimum of 2 years’ experience with QA/document control in industry required
  • Experience working in ISO 9001 or 13485 certified organization required
  • Demonstrated experience with Quality Management System, and audit activities required
  • Experience or knowledge with root cause analysis techniques required
  • General understanding of the training, calibration and inventory processes required
  • Demonstrated attention to detail and excellence in written communication


Additional Skills:


  • Experience as lead resource with document control software preferred
  • Certification as Internal Auditor preferred
  • Previous R&D/technical industry exposure, able to understand company technology at a practical level
  • Excellent documentation, communication, and interpersonal relationship skills
  • Strong problem-solving, organizational, analytical, and critical thinking skills
  • Ability to navigate uncertainty/fluidity in role scope, priorities, and timelines
  • Ability to manage competing priorities in a fast-paced and dynamic environment
  • Proven expertise in usage of MS Office Suite


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

  • Specialist, Quality Assurance

    2 months ago

    Calgary, Canada CB Canada Full time

    Specialist, Quality AssuranceOn behalf of our client, Procom is seeking a Specialist, Quality Assurance for a 6 month contract in Calgary, AB.Specialist, Quality Assurance Job DetailsThe Specialist, Quality Assurance will co-ordinate the day to day testing activities for multiple integration projects.Specialist, Quality Assurance Responsibilities The...

  • Specialist, Quality Assurance

    1 week ago

    Calgary, Canada CB Canada Full time

    Specialist, Quality AssuranceOn behalf of our client, Procom is seeking a Specialist, Quality Assurance for a 6 month contract in Calgary, AB.Specialist, Quality Assurance Job DetailsThe Specialist, Quality Assurance will co-ordinate the day to day testing activities for multiple integration projects.Specialist, Quality Assurance Responsibilities The...

  • Quality Specialist

    4 weeks ago

    Calgary, Canada Fluid Biomed Inc. Full time

    This is a unique opportunity to join a 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...

  • Quality Specialist

    4 weeks ago

    Calgary, Canada Fluid Biomed Inc. Full time

    This is a unique opportunity to join a 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...

  • Quality Specialist

    4 weeks ago

    Calgary, Canada Fluid Biomed Inc. Full time

    This is a unique opportunity to join a 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...

  • Quality Control Specialist

    13 hours ago

    Calgary, Canada Mainstreet Equity Corp. Full time

    **Position Title**:Quality Control Specialist **Department**:Corporate **Reports to**:VP Operations **Level**:Non-Management **Position Summary** Reporting to the CVP Operations, the **Quality Control Specialist **will be responsible for ensuring that all projects/renovations meet the highest standards of quality. This role will also be responsible for...

  • Quality Specialist

    4 weeks ago

    Calgary, AB, Canada Fluid Biomed Inc. Full time

    This is a unique opportunity to join a 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...

  • Quality Specialist

    4 weeks ago

    Calgary, AB, Canada Fluid Biomed Inc. Full time

    This is a unique opportunity to join a 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...

  • Quality Specialist

    4 weeks ago

    Calgary, AB, Canada Fluid Biomed Inc. Full time

    This is a unique opportunity to join a 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...

  • Quality Assurance Specialist

    2 months ago

    Calgary, Canada Peloton Full time

    **Quality Assurance Specialist - Land Data Management** Reports To: Web Development Manager Job Summary: Supervisory Responsibilities: - None Office setting: Full time, in office. Primary Job Responsibilities: - Validate the work of the development team and test new and existing features. - Develop automated test scripts to create repeatable UI...

  • Air Quality Sales Specialist

    1 week ago

    Calgary, Canada Nova Caeli Inc. Full time

    _**Immediate Opening for One (1) Full Time Permanent Position **_ Work Location: Calgary, Alberta Nova Caeli is looking for a dynamic, agile, solution focused and experienced Air Quality Sales Specialist. When it comes to Environmental Consulting, we’re focused on cleaning up our communities today to improve tomorrow. We’re seeking an Air Quality Sales...

  • Specialist, Process

    1 week ago

    Calgary, Canada H2 Safety Full time

    Celebrating our 20th anniversary in 2024, H2Safety Services Inc. is the largest Emergency Response Management provider in Canada. Equipped with decades of experience, our team of industry leading experts deliver comprehensive, tailored Emergency Management, Health, Safety, and Environment (HSE), Emergency Response Training, and Technology services to...

  • Quality Control Specialist

    2 weeks ago

    Calgary, Canada Newrest Full time

    Want to join us? Labor SUMMARY: The Quality Control Specialist will assist in maintaining the Unit's food safety policies, procedures, and initiatives. This individual collaborates with departments to ensure compliance with relevant regulations and promote a culture of food safety. Responsibilities:  Maintain and review quality documentation...

  • Quality Control Specialist

    1 week ago

    Calgary, Canada Newrest Full time

    Want to join us? Labor SUMMARY: The Quality Control Specialist will assist in maintaining the Unit's food safety policies, procedures, and initiatives. This individual collaborates with departments to ensure compliance with relevant regulations and promote a culture of food safety. Responsibilities:  Maintain and review quality documentation...

  • Quality Control Specialist

    1 week ago

    Calgary, Canada Critical Mass Full time

    As a Quality Control Specialist, you are an excellent communicator who is able to work closely with Producers, Design Supervisors, Production Designers, Studio Artists and Technical artists to ensure assets are successfully delivered without errors. Mitigating risks and managing QC can be challenging, but your organizational and interpersonal skills are up...

  • Quality Assurance Specialist

    2 weeks ago

    Calgary, Canada Cardinal Health Full time

    Cardinal Health, with over 1300 employees in Canada, is an essential link in the Canadian healthcare supply chain, providing over 70,000 products to healthcare facilities and medical professionals across the country. Cardinal Health is seeking a positive individual to join the Regulatory Affairs and Quality Assurance team as a Quality Assurance Specialist....

  • Veterinary Receptionist, Client Care

    1 month ago

    Calgary, Canada Western Veterinary Specialist & Emergency Centre Full time

    **Western Veterinary Specialist & Emergency Centre** is currently welcoming a customer service focused **Veterinary Reception, Client Care Specialist** to join our clinic. This **full-time rotation** opportunity includes a range of responsibilities which directly attributes to the efficient and effective daily operation of the hospital. Your primary...

  • Quality Controller

    1 week ago

    Calgary, Canada ARPI'S INDUSTRIES LTD Full time

    **Residential New Home HVAC Quality Control** ARPIS INDUSTRIES is Calgary's number one residential new home installation company and the largest LENNOX dealer in Alberta. **Quality Control Specialist for Residential New Home HVAC** Are you passionate about ensuring excellence in HVAC installations for new residential homes? Do you have hands-on experience...

  • Quality & Food Safety Specialist

    4 days ago

    Calgary, Canada Archer Daniels Midland Company Full time

    Calgary Canada Quality & Food Safety **Quality & Food Safety Specialist** **Location** Calgary, Alberta **Position Type** Operations **Salary** Full-Time, Exempt **Compensation **This position offers a complete benefit package, retirement, health, life, vision and dental insurance **Pre-employment Requirement **Successful completion of pre-employment...

  • Quality Assurance Specialist

    1 week ago

    Calgary, Canada ATB Financial Full time

    Our Bottom Line is Different.There’s something special about working at ATB, and it’s been recognized on every top employer list that matters. Maybe it’s our exceptional culture where your total wellness is supported through market-leading benefits and you’re free to bring your whole self to work. Maybe it’s our commitment to a growth mindset and...