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 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 standardsManage 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) libraryComplete receiving documentation for incoming parts, components, or equipmentPrepare and lead annual QMS Management Review meetings and present to the team and executivesAct as Management Representative in coordinating regulatory compliance activities/audits with external regulatory affair bodies to obtain and maintain necessary ISO certifications and approvalsUnder ISO 13485 requirements, maintain and execute the internal audit process to assess compliance with QMS requirements and identify areas for improvementsEstablish and maintain key performance indicators (KPIs) to monitor product quality and process effectivenessLead and improve product inspection activities, including the development of standard inspection reports, and communicating with internal and external stakeholdersInitiate, 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 mannerOwn and maintain Approved Supplier List (ASL) including qualification, approval, development of quality agreements, and performance evaluation of suppliers in coordination with Engineering teamAssist in the procurement and installation of necessary quality and operational equipment by preparing request for quotes (RFQs), shipping documentation, technical qualification documentation, etc. as requiredMaintain supplier quality documentation including Certificate of Analysis, inspection reports, etc.Execute Non-Disclosure Agreements (NDAs) for external service providers, as requiredManage overall equipment calibration process including maintenance of calibration/maintenance reports, and coordinate ongoing equipment service or testing, in coordination with the Engineering teamManage overall inventory control process including physical and electronic inventory of conforming/non-conforming product, delivery components, and supporting equipmentManage overall training program and maintain training KPI reports, matrix, files, and records for all staffProvide training and education to staff on quality processes, procedures, and regulations as requiredLead and support continuous improvement project activities across the organizationSupport other Quality Department activities as requiredEducation and Experience Requirements:Bachelor’s degree and a minimum of 2 years’ experience with QA/document control in industry requiredExperience working in ISO 9001 or 13485 certified organization requiredDemonstrated experience with Quality Management System, and audit activities requiredExperience or knowledge with root cause analysis techniques requiredGeneral understanding of the training, calibration and inventory processes requiredDemonstrated attention to detail and excellence in written communicationAdditional Skills:Experience as lead resource with document control software preferredCertification as Internal Auditor preferredPrevious R&D/technical industry exposure, able to understand company technology at a practical levelExcellent documentation, communication, and interpersonal relationship skillsStrong problem-solving, organizational, analytical, and critical thinking skillsAbility to navigate uncertainty/fluidity in role scope, priorities, and timelinesAbility to manage competing priorities in a fast-paced and dynamic environmentProven expertise in usage of MS Office SuiteRole is on-site in Calgary, AB and candidates must be legally entitled to work full time in Canada.

  • 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...

  • 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 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...

  • Specialist Quality

    3 weeks ago

    Edmonton, AB, Canada CanAm Physician Recruiting Inc. Full time

    The North, Central and South Zone Hospitals in Alberta are currently accepting applications for a full-time Emergency Medicine Specialists or CCFP EM. Establish and maintain a full time clinical practice in the Zone Clinical Department of Emergency Medicine; Obtain and maintain an AHS Medical Staff Appointment and appropriate privileges to provide the...

  • Quality Control Specialist

    1 day 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 Engineering Specialist

    2 months ago

    Edmonton, AB, Canada ABB Schweiz AG Full time

    Quality & Continuous Improvement Specialist Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities, ethnicity and generations....

  • Electrical Quality Assurance Specialist

    1 month ago

    Calgary, AB, Canada Collage HR Full time

    Tetranex Solutions is a Calgary-based, full-discipline engineering and procurement company focused on client service and quality execution. As a privately held company, our team understands the importance of forming and maintaining great relationships with our customers by delivering outstanding products and services. With extensive experience across...

  • 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...

  • Quality & Continuous Improvement Specialist

    2 months ago

    Edmonton, AB, Canada ABB Schweiz AG Full time

    Quality & Continuous Improvement Specialist Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities, ethnicity and generations....

  • Quality Technician

    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...

  • 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

    3 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

    2 weeks 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....