QA/RA Associate

2 days ago

Markham, Ontario, Canada Fluidigm Full time $60,000 - $90,000 per year


Job Description

It is an extraordinary time for Standard BioTools. Our technology is empowering customers to improve life through comprehensive health insight. We invite you to join a leading provider of indispensable life sciences tools that is accelerating global research on multiple frontiers of human health.

At Standard BioTools, we are building a positive culture where our people can do the best work of their careers, informed, and influenced by our core behaviors:

  • Keep customers front and center in all of our work
  • Be accountable and deliver on commitments
  • Drive continuous improvement
  • Be collaborative and work as one team: fostering communications in a learning, coaching, and helpful environment

Standard BioTools is looking for a Quality Assurance/Regulatory Affairs Associate to support the products' quality and regulatory activities. The Quality Assurance and Regulatory Affairs associate is responsible for maintaining and ensuring that the company quality system meets requirements for medical devices, and International Directives. The QA/RA Associate is also responsible for ensuring that products and their labeling meet all regulatory requirements (national and international) such as REACH, RoHS, WEEE, CE, etc.

Description

  • Maintain Technical Documentation files in compliance with international requirements.
  • Oversee the company REACH and Safety Data Sheet program.
  • Approval and release of Quality Records, Device History Records, Batch Records Master Labels and Device Master Records.
  • Support and administration of risk assessment review process and implementation of changes to risk management process as needed.
  • Liaison with domestic and international customers and vendors to ensure compliance with standards and execution of corrective actions.
  • Development of controlled documents and procedures pertinent to Quality Assurance activities and functions.
  • Assists with customer complaints/CAPA system.
  • Supports new product development, risk analysis, and launch processes, and manage QA participation on new production development.

Minimum Qualifications:

  • Bachelor's degree required, life science / engineering.
  • Regulatory Affairs / Quality Management RAC certificate is preferred.
  • Experience with ISO 13485, ISO 9001, required.
  • Knowledge of and experience with the following standards: IEC , ISO 13485, ISO 14971, IEC 62366, IEC 62304, CE-IVDR and 21 CFR 820.
  • Knowledge with REACH, RoHS, WEEE, CE mark, UKCA directives and Safety Data Sheet compliance.
  • ASQ Certification preferred but not required (such as CQA, CQE, CMQ/OE).
  • 1-2 years of industry experience preferred.
  • ISO 13485 Internal Auditor certificate a plus.
  • Salesforce Experience a plus.
  • Basic knowledge of Excel.
  • Fast learner, self-starter, accountable, reliable.
  • Ability to successfully work in a dynamic environment.
  • Able to work under pressure and tight timelines.
  • Problem solving attitude.
  • Cross-functional perspective and coordination.

The Company is committed to providing an inclusive and barrier free recruitment process to applicants with accessibility needs in accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act (AODA). If you require an accommodation during this process, please inform The Company of your requirements.  We are an equal opportunity employer.


  • Senior Software Test Engineering – AVIP Diagnostics QA

    2 days ago

    Markham, Ontario, Canada General Motors Full time $80,000 - $120,000 per year

    Job DescriptionWork Arrangement:Hybrid: This role is categorized as hybrid. This means the successful candidate is expected to report to Markham Elevation Centre (MEC) three times per week at minimum, or other frequency dictated by the business.General Motors is transforming the future of mobility – and the Canadian Technical Centre (CTC) is at the...

  • Senior Software Test Engineering – AVIP Diagnostics QA

    4 days ago

    Markham, Ontario, Canada General Motors Full time US$90,000 - US$200,000 per year

    Job DescriptionWork Arrangement: Hybrid: This role is categorized as hybrid. This means the successful candidate is expected to report to Markham Elevation Centre (MEC) three times per week at minimum, or other frequency dictated by the business.General Motors is transforming the future of mobility – and the Canadian Technical Centre (CTC) is at the...

  • Quality Technician

    2 days ago

    Markham, Ontario, Canada ProAmpac Full time $60,000 - $90,000 per year

    Essential Duties And TasksFollow all safety policies and procedures.Responsible for in-process inspection and test verification for Quality, Packaging Safety and other requirements.Ensure all QA bench-top test equipment is calibrated and functioning properly.Responsible for documentation, sampling and quarantining of non-conforming material. Maintains other...

  • DevOps Engineer

    7 days ago

    Markham, Ontario, Canada ZRG Careers Full time $80,000 - $120,000 per year

    DevOps EngineerRole:Our client has an an exciting opportunity for a DevOps Engineer. This position is responsible for executing tactical implementations of the Software Center of Excellence DevOps Frameworks, monitoring and processes. This is a associate to mid-level role on a team of DevOps engineers and drives the successful execution of the continuous...

  • QUAC-Quality Assurance Coordinator

    7 days ago

    Markham, Ontario, Canada Lifemark Health Group Full time $60,000 - $80,000 per year

    Viewpoint North York-Quality Assurance CoordinatorLocation:Viewpoint North York235 Yorkland Boulevard, Suite 1200, North York, ON M2J 4Y8Status:Full-time, hybrid and full-time remote options availableAbout ViewpointViewpoint is the leading provider of high quality, defensible independent medical assessments. We are Canada's largest IME company, delivering...

  • Sr. Water Resources Engineer and Project Mgr

    6 days ago

    Markham, Ontario, Canada Stantec Full time $80,000 - $125,000 per year

    Description"Strong communities don't just happen—they're built. They're creatively imagined, collaboratively planned, and readied to face tomorrow with optimism. We're driving the future of Community Development. Our experts lead their fields, collaborating on projects that are as technically challenging as they are impactful, creative, and fulfilling....

  • Network Technician/Engineering Support

    1 week ago

    Markham, Ontario, Canada Compucom Full time $60,000 - $90,000 per year

    Compucom Systems, Inc. provides end-to-end IT managed services to enable the digital workplace for enterprise, midsize and small businesses. To enable our clients to focus on what matters most, we employ a customer-centric, hard-working, and talented group of people that Act Like an Owner, Do the Right Thing, and Have Fun Doing It We're looking for a Network...

  • ERP Functional Analyst, Supply Chain

    3 hours ago

    Markham, Ontario, Canada Pet Valu Full time US$86,000 - US$140,000 per year

    Hybrid: Markham, OntarioJob DescriptionJob OverviewTheERP Functional Analyst – Supply Chainplays a critical role within the IT Enterprise Applications team by bridging the gap between business needs and technical solutions in the D365 Finance & Operations (F&O) platform. This role partners closely with Supply Chain and Merch stakeholders (e.g., Inventory...

  • Junior QA Engineer | North America | Canada | Europe | Fully Remote

    4 weeks ago

    Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Victoria, Surrey, Halton Hills, London, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southwestern Ontario, R, Canada QA Full time

    OverviewJunior QA Engineer | North America | Canada | Europe | Fully Remoteat Escape Velocity Entertainment What we are looking forEscape Velocity is looking for a motivated and detail-oriented Junior QA Engineer to join our team. The ideal candidate will have a strong foundation in quality assurance practices and video game industry standard engines, such...

  • QA Engineer

    3 days ago

    Markham, Canada Mekari Full time

    Join to apply for the QA Engineer role at Mekari . Get AI-powered advice on this job and access more exclusive features. Read requirements, design/write, and review test cases. Collaborate with developers, product owners, and other related teams to understand feature expectations. Define and design negative and edge cases, aiming for 100% test case coverage....

  • AI Prompt Quality Assurance

    2 weeks ago

    Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Surrey, Victoria, London, Halton Hills, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southwestern Ontario, R, Canada Taskify AI Full time

    AI Prompt Quality Assurance (QA) Associate Taskify AI is hiring a flexible, 100% remote QA Associate to support day‑to‑day tasks, ensure smooth operations, and contribute to digital, content, research, data, and AI‑related workflows. Key Responsibilities Assist with everyday tasks based on project needs (content, data, research, analysis, operations,...

  • AI Prompt Quality Assurance

    1 week ago

    Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Surrey, Victoria, London, Halton Hills, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southwestern Ontario, R, Canada Taskify AI Full time

    AI Prompt Quality Assurance (QA) Associate Join to apply for the AI Prompt Quality Assurance (QA) Associate role at Taskify AI We are hiring motivated individuals for a Flexible 100% remote role that involves supporting day‑to‑day tasks, ensuring smooth operations, and contributing to digital, content, research, data, and AI‑related workflows. Flexible...

  • QA Analytical Data Reviewer

    2 weeks ago

    Markham, Canada Shields Pharma Inc. Full time

    **About Shields Pharma Inc.** Shields Pharma Inc. is a Health Canada approved GMP organization located in Markam, Ontario. We offer Laboratory R&D and QC testing services as well as production and formulation of psychedelic therapeutics for treatment of certain mental health disorders such as anxiety, depression, obsessive-compulsive disorder, PTSD, and...

  • Food Safety and Quality Assurance Associate

    2 weeks ago

    Markham, Canada Lafayette Sweets Full time

    Founded in 1998, Lafayette Group of Companies is headquartered in the Canadian High Tech Center in Markham, Toronto. “Lafayette” is a multinational company in both North America and Asia that manufacturing, processing and distributing baking products and providing technical support for various companies such as airlines, hotels, cafes, retail and grocery...

  • Remote AI Prompt QA Associate | Flexible Hours

    1 week ago

    Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Surrey, Victoria, London, Halton Hills, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southwestern Ontario, R, Canada Taskify AI Full time

    A tech company is looking for an AI Prompt Quality Assurance (QA) Associate. This remote role offers flexible hours and requires no prior experience. Responsibilities include supporting tasks across digital, content, research, and AI workflows while ensuring accuracy and effective communication. The ideal candidate is eager to learn and has strong English...

  • Quality Assurance Associate

    1 week ago

    Markham, Canada Astellas Full time

    **Astellas Canada - People Operations Partner** At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients. **What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the...

  • Regulatory Compliance Associate

    1 week ago

    Markham, Canada Kelly Engineering Full time

    Job Description: The primary responsibility of the Compliance Associate, Regulatory Affairs will be to input product, formulation and ingredient information into a global ingredient database to enable compliance with the Canadian Environmental Protection Regulations. LIST JOB RESPONSIBILITIES: - Work with the internal team in the US to obtain ingredient...

  • Software Engineer 2

    4 weeks ago

    Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Victoria, Surrey, Halton Hills, London, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southwestern Ontario, R, Canada Personify Full time

    QA Software Engineer 2 - SDET We’re looking for a QA Software Engineer 2 to join the Research & Development team where the role is responsible for ensuring quality software solutions are delivered to our customers. You will collaborate with other software engineers, product owners and designers to understand business requirements and contribute by...