Quality Specialist
2 weeks ago
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.
-
Quality Specialist
1 month ago
Toronto, ON, Canada TalentWorld Full timeAre you ready to dive into the exciting world of quality assurance and make a significant impact? We're on the lookout for a Quality Assurance Specialist to join our client in Mississauga ! As a Quality Assurance Specialist, you'll play a crucial role in ensuring our processes and policies meet the highest standards. Quality Assurance Specialist...
-
Quality Specialist
2 days ago
Toronto, Canada Stefanini, Inc Full time**Stefanini Group is hiring!** **Stefanini is looking for Quality Specialist in Toronto, ON CAD (Onsite)** **For quick Apply, please reach out to Krisha Lago -** Under the direction of the Quality Supervisor, this role will be responsible for performing scheduled and unscheduled quality audits, inspection and testing of products, as well as audits to the...
-
Quality Specialist
2 weeks ago
Toronto, Canada Fluid Biomed Inc. Full timeThis 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
2 weeks ago
Toronto, Canada Fluid Biomed Inc. Full timeThis 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...
-
Crypto Quality Assurance Specialist
2 weeks ago
Toronto, Canada Zetatech Services Inc Full timeRole Description This is a part-time remote role for a Quality Assurance Specialist. The Quality Assurance Specialist will be responsible for conducting quality control and quality assurance checks, implementing Good Manufacturing Practices (GMP), managing quality control systems, and conducting qu
-
Quality Assurance Specialist
4 weeks ago
Toronto, Canada Lush Handmade Cosmetics Full time**Quality Assurance Specialist, Web, Digital & Operations** The **Quality Assurance Specialist** plays an essential role in growing talent in our business through collaboration and sharing best practices with the** Web Development** team. You know how to be curious about their opportunities, and how to be real with feedback and support. To be successful in...
-
Quality Assurance Specialist
4 weeks ago
Toronto, Canada Internal Job Board Full time**Quality Assurance Specialist, Web, Digital & Operations** The **Quality Assurance Specialist** plays an essential role in growing talent in our business through collaboration and sharing best practices with the** Web Development** team. You know how to be curious about their opportunities, and how to be real with feedback and support. To be successful in...
-
Quality Specialist I
3 days ago
Toronto, Canada Axelon Services Corporation Full timeJob Title: Quality Specialist ILocation: Toronto, ON.Hours: 9 am - 5 pm rotating shiftsJob Description :On-the-line/shop floor activities. Hold and release/control of non-conforming product. Regular line checks, metal detection checks and ATP swabbing. Monitoring Allergens and responsible for microanalysis and allergen testing on the necessary products and...
-
Specialist, Quality Assurance
4 weeks ago
Toronto, Canada First National Financial Full timeWorking together to be our best! First National is Canada’s largest non-bank lender, originating and servicing both commercial and residential mortgages since 1988. Over the past thirty years, we have been committed to hiring the best and brightest with over 1,000 proud team members. Through cooperation, ongoing coaching, development opportunities and a...
-
Crypto Quality Assurance Specialist
1 month ago
Toronto, Canada Zetatech Services Inc Full timeRole DescriptionThis is a part-time remote role for a Quality Assurance Specialist. The Quality Assurance Specialist will be responsible for conducting quality control and quality assurance checks, implementing Good Manufacturing Practices (GMP), managing quality control systems, and conducting quality audits.Your responsibilities will include:Designing and...
-
Crypto Quality Assurance Specialist
4 weeks ago
Toronto, Canada Zetatech Services Inc Full timeRole DescriptionThis is a part-time remote role for a Quality Assurance Specialist. The Quality Assurance Specialist will be responsible for conducting quality control and quality assurance checks, implementing Good Manufacturing Practices (GMP), managing quality control systems, and conducting quality audits.Your responsibilities will include:Designing and...
-
Crypto Quality Assurance Specialist
1 month ago
Toronto, Canada Zetatech Services Inc Full timeRole Description This is a part-time remote role for a Quality Assurance Specialist. The Quality Assurance Specialist will be responsible for conducting quality control and quality assurance checks, implementing Good Manufacturing Practices (GMP), managing quality control systems, and conducting quality audits. Your responsibilities will include: Designing...
-
Crypto Quality Assurance Specialist
1 month ago
Toronto, Canada Zetatech Services Inc Full timeRole Description This is a part-time remote role for a Quality Assurance Specialist. The Quality Assurance Specialist will be responsible for conducting quality control and quality assurance checks, implementing Good Manufacturing Practices (GMP), managing quality control systems, and conducting quality audits. Your responsibilities will include: Designing...
-
Crypto Quality Assurance Specialist
1 month ago
Toronto, Canada Zetatech Services Inc Full timeRole Description This is a part-time remote role for a Quality Assurance Specialist. The Quality Assurance Specialist will be responsible for conducting quality control and quality assurance checks, implementing Good Manufacturing Practices (GMP), managing quality control systems, and conducting quality audits. Your responsibilities will include: Designing...
-
Bilingual Quality Assurance Specialist
1 week ago
Toronto, ON, Canada TalentWorld Full timeAre you ready to dive into the exciting world of quality assurance and make a significant impact? We're on the lookout for a Quality Assurance Specialist to join our client in Mississauga ! As a Quality Assurance Specialist, you'll play a crucial role in ensuring our processes and policies meet the highest standards. Here's your chance to...
-
Pharmaceutical Quality Specialist
1 month ago
Toronto, Canada Isologic Innovative Radiopharmaceuticals Full time**ISOLOGIC Innovative Radiopharmaceuticals** offers you an exceptional opportunity to join our dynamic team as a Pharmaceutical Quality Specialist! If you’re passionate about upholding high-quality standards, nuclear medicine, and want to make a significant contribution to patient care while working in a stimulating and dynamic environment, then this...
-
Crypto Quality Assurance Specialist
1 month ago
Toronto, Canada Zetatech Services Inc Full timeRole Description This is a part-time remote role for a Quality Assurance Specialist. The Quality Assurance Specialist will be responsible for conducting quality control and quality assurance checks, implementing Good Manufacturing Practices (GMP), managing quality control systems, and conducting quality audits.Your responsibilities will include: Designing...
-
Quality Assurance Specialist
6 days ago
Toronto, Canada MADISON HOMES HOLDINGS Full timeGeneral Description: The Quality Assurance Specialist reports to the Quality Assurance Manager and works in conjunction with Sales, Project Management, Construction, Customer Care and Property Management across all Madison Group Communities in relation to the Quality Control, PDI, Occupancy and Audit Phases of a community. Primary Responsibilities: -...
-
Crypto Quality Assurance Specialist
4 weeks ago
Toronto, Canada Zetatech Services Inc Full timeRole DescriptionThis is a part-time remote role for a Quality Assurance Specialist. The Quality Assurance Specialist will be responsible for conducting quality control and quality assurance checks, implementing Good Manufacturing Practices (GMP), managing quality control systems, and conducting quality audits.Your responsibilities will include:Designing and...
-
Crypto Quality Assurance Specialist
1 month ago
Toronto, Canada Zetatech Services Inc Full timeRole DescriptionThis is a part-time remote role for a Quality Assurance Specialist. The Quality Assurance Specialist will be responsible for conducting quality control and quality assurance checks, implementing Good Manufacturing Practices (GMP), managing quality control systems, and conducting quality audits.Your responsibilities will include:Designing and...