Quality Assurance Specialist

3 weeks ago

Burnaby, Canada Kardium Full time

**Your opportunity**
By joining the Kardium team, you can help make a difference in the lives of millions around the world. We have developed a ground-breaking medical device for the mínimally invasive diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation. Atrial fibrillation can cause stroke, heart failure, and other heart-related complications.
Kardium has a fantastic technical team that has developed a product with strong, unique and customer-valued differentiators versus other solutions on the market: The Globe® Pulsed Field System. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story.
Kardium has a unique opportunity for several experienced Quality Assurance (QA) Specialists. As members of the QA Team, our QA Specialists provide direct QA support to the Manufacturing and Engineering teams, and contribute to the continuous improvement and maintenance of Kardium's Quality Management System (QMS).
**What you'll be doing**
Your responsibilities will include:
**QA support to Manufacturing team**
- Conduct the QA review of production Device Master Record documentation, including work instructions and traveller templates
- Perform QA review of production documentation associated with quality issues, including deviations, nonconformities, discrepancies, and reworks
- Perform QA review of Device History Records (DHRs) to support finished goods release
- Review and execute the QA release of incoming materials and in-process goods
- Assist with root cause investigation (e.g. targeted DHR review)
- Conduct the QA review of equipment documentation, including but not limited to qualification, maintenance, and calibration records

**QA support to Engineering team**
- Review verification and validation documentation, including but not limited to test plans and reports for equipment qualification, process validation, engineering studies, design verification, engineering change requests, etc.
- Provide QA input into process validation activities
- Conduct the QA review of software tool implementation and validation documentation, such as requirements documents, validation plans, test protocols, test reports, etc.
- Participate in the QA coordination of change control activities

**QMS support**
- Participate in Kardium's internal audit program as needed
- Oversee and manage various QMS project activities assigned to QA
- Perform document control tasks such as assuring that the review and approval of controlled documents is in accordance with Kardium policies and procedures, and maintaining quality records per established procedures
- Perform other QA tasks as required

**What you bring to the team**
Our Kardium team is smart, creative, and passionate about developing cutting-edge medical devices to help improve people's lives. We work in a collaborative environment based on trust and respect. We understand that only by working together can we solve what was thought unsolvable.
You are suited to our approach and possess these attributes:
**Education & Experience**
- Bachelor of science degree in a technical discipline (e.g., engineering, pharmaceutical sciences, biotechnology, etc.)
- At least 3 years' QA experience in a manufacturing environment in the biotechnology industry; experience in QMS planning and implementation an asset
- Strong, in-depth, working knowledge of ISO 13485, FDA QSR and QMS requirements of the European MDD; organizational awareness of quality management system implementation and operations
- Thorough knowledge of documentation and record control systems; experience with electronic document and electronic record management systems an asset

**Skills**
- Strong analytical skills and critical thinking
- Effective written and verbal communication and technical documentation skills
- High proficiency in MS Word/Excel an asset
- Able to operate independently with mínimal direction
- Work efficiently with the ability to be innovate and identify creative solutions
- Complete multiple tasks in a timely and thorough manner (i.e. organized and detail-oriented)
- Excellent interpersonal skills including the ability to resolve conflict with poise, diplomacy, and tact
- Ability to work effectively as part of a team and collaborate with staff at all levels
- Flexible and adaptable to take on additional responsibilities as appropriate

**Why work at Kardium**
A meaningful career working with a truly innovative technology and an ambitious team, combined with:

- Knowing every day that you are making a difference in people's lives by helping treat a condition that debilitates millions worldwide
- A great working environment with opportunities to develop your skills and knowledge
- Opportunity to extend your knowledge by interacting with other team members in a multi-disciplinary environment that includes electrical and mechanical engineers, biologists, and specialists in human factors, and clinical and regulato

  • Quality Assurance Specialist

    4 weeks ago

    Burnaby, Canada Canda Six Fortune Enterprise Full time

    **Title** - Quality Assurance Specialist **Categories** - Permanent, Full-time **Location** - Burnaby, BC **Job Information** Canda Six Fortune Enterprise Co. Ltd. is one of the leading importers and distributors of Asian food products from the Pacific Rim and other regions of the world. We are currently looking for a team-player to help us promote high...

  • Quality Assurance Specialist

    1 month ago

    Burnaby, Canada Canda Six Fortune Enterprise Full time

    **Title** - Quality Assurance Specialist / Assistant **Categories** - Permanent, Full-time **Location** - Burnaby, BC **Job Information** Canda Six Fortune Enterprise Co. Ltd. is one of the leading importers and distributors of Asian food products from the Pacific Rim and other regions of the world. We are currently looking for a team-player to help us...

  • Quality Specialist

    3 weeks ago

    Burnaby, Canada Svante Full time

    **About Svante** Svante is a purpose-driven, rapidly growing clean technology company based in Burnaby, BC, Canada, and we’re on a mission to help the world reach net zero with filters and machines that capture and remove CO2 from industrial emissions and the air. We’re a collaborative, diverse group of people who care about the planet and, through our...

  • Specialist - Sales Associate

    4 weeks ago

    Burnaby, BC, Canada Residential Sales Specialist Full time

    Volunteer Experience · Work Experience · Work & Career RESIDENTIAL SALES SPECIALIST JOB DESCRIPTION Term: Full time, 40 hours/Per Week LX Hausys is an international building and decorative material company who have been in operation for over 70 years. We provide a variety of solutions that can revitalize a space through its business in the fields of...

  • Specialist, Quality Assurance

    4 weeks ago

    Burnaby, Canada New Beta innovation canada Ltd. Full time

    **ABOUT THE COMPANY** New Beta Innovation Canada Limited (NBI-CA) is a biopharmaceutical manufacturer of hemoglobin-based therapeutics. In Burnaby, BC, we have a state-of-the-art Good Manufacturing Practice (GMP) compliant facility, with custom-designed equipment for commercial-scale production. Our production processes are undergoing validation for...

  • Quality Assurance Assistant

    6 days ago

    Burnaby, Canada Artron Bioresearch Inc Full time

    **About Us** Artron is a leader in the medical devices industry, specializing in rapid diagnostics products. Headquartered in British Columbia, our operations span globally to meet the various needs of partners around the world. We pride ourselves on providing the best products and customer service to our clients through our innovative technology and...

  • Quality Assurance Assistant

    4 weeks ago

    Burnaby, Canada Canda Six Fortune Enterprise Full time

    **Title** - Quality Assurance Assistant **Categories** - Permanent, Full-time **Location** - Burnaby, BC **Job Information** Canda Six Fortune Enterprise Co. Ltd. is one of the leading importers and distributors of Asian food products from the Pacific Rim and other regions of the world. We are currently looking for a team-player to help us promote high...

  • Quality Assurance

    6 days ago

    Burnaby, Canada Bluvec Technologies Inc. Full time

    About Company: Burnaby - based, Bluvec Technologies Inc., founded in 2018, is one of the most enthusiastic start-up companies to model the future for wireless security. With core designers from Microsoft, Viavi, Fortinet, we focus on designing best in class wireless security products which provide detection, localization, controlling, and protecting of...

  • Quality Assurance Analyst

    1 month ago

    Burnaby, Canada Bluebits Technologies Inc Full time

    QA tester responsibilities include designing and implementing tests, debugging and defining corrective actions. **Responsibilities** - Design test plans, scenarios, scripts, or procedures. - Document software defects, using a bug tracking system, and report defects to software developers. - Identify, analyze, and document problems with program function,...

  • systems quality assurance

    4 weeks ago

    Burnaby, Canada COHASH IT SERVICES INC. Full time

    Education: Expérience: EducationSecondary (high) school graduation certificateTasksDesign, develop and implement information systems business solutionsDevelop and implement policies and procedures throughout the software development life cycleConduct reviews to assess quality assurance practices, software products and information systemsOperate automatic or...

  • Assistant Manager, Quality Assurance

    4 weeks ago

    Burnaby, Canada New Beta Innovation Canada Ltd. Full time

    **ABOUT THE COMPANY** New Beta Innovation Canada Limited (NBI-CA) is a biopharmaceutical manufacturer of hemoglobin-based therapeutics. In Burnaby, BC, we have a state-of-the-art Good Manufacturing Practice (GMP) compliant facility, with custom-designed equipment for commercial-scale production. Our production processes are undergoing validation for...

  • Quality Assurance Rep 1

    1 month ago

    Burnaby, Canada BC Hydro Full time

    Hours of work: Full-time (37.5 hrs/wk) Flexible Work Role: Hybrid Annual salary: $ 75,800.00 - 81,700.00 **What you'll do** - Provides inspection and quality assurance (QA) evaluation services to departments within BC Hydro (primarily Engineering, Project Delivery and Materials Management) and to external clients. - Attends pre-job and pre-bid...

  • Project Lead, Quality Assurance

    4 weeks ago

    Burnaby, Canada New Beta innovation canada Ltd. Full time

    **ABOUT THE COMPANY** Our state-of-the-art GMP manufacturing facilities and laboratories in Greater Vancouver are home to a growing team of professionals who are inspired to develop advanced life-saving hemoglobin-based therapeutics for the well-being of people. **POSITION OVERVIEW** Reporting to the Senior Manager, Quality Assurance (Compliance), the...

  • Quality Assurance Tester

    1 month ago

    Burnaby, Canada PHSA Full time

    **What you’ll do** - Work closely with the business SME’s and the vendor to create and modify test cases and test scripts. - Plan and execute software functional testing and systems integration testing, recording results and communicating with the QA Lead and/or Project Manager on testing progress. - Participate in defect triaging. - Prepare regression...

  • Quality Assurance

    1 month ago

    Burnaby, Canada Bluebits Technologies Inc Full time

    At Bluebits, we offer tremendous opportunities in developing your expertises, honing your skill sets, and building your career alongside a team of passionate, empowered, and engaged industry professionals. Bluebits is proud to offer a caring, open-minded, diverse working environment. Bluebits Technologies is headquartered in Burnaby, BC, and is committed to...

  • QHSSE Specialist

    2 days ago

    Burnaby, Canada Chamber of Shipping of British Columbia Full time

    Headquartered in Burnaby, B.C., Tidewater Canada (TWC) is the West Coast’s largest bulk transporter of refined petroleum products. Our services include bulk fuel transportation, specialty towing and marine logistics. We are currently seeking a QHSSE Specialist who will be responsible for maintaining effective quality, health, safety, security, and...

  • QHSSE Specialist

    1 day ago

    Burnaby, Canada Chamber of Shipping of British Columbia Full time

    Headquartered in Burnaby, B.C., Tidewater Canada (TWC) is the West Coast’s largest bulk transporter of refined petroleum products. Our services include bulk fuel transportation, specialty towing and marine logistics. We are currently seeking a QHSSE Specialist who will be responsible for maintaining effective quality, health, safety, security, and...

  • Product Management Specialist

    1 month ago

    Burnaby, Canada Fortinet Full time

    DescriptionThe successful candidate will join the Product Management team and specialize in Public & Private Cloud solution documentation. In this position you would be responsible for sourcing, compiling and publishing technical customer-facing content related to our public and private cloud offerings. You will interact with colleagues globally across...

  • Product Management Specialist

    4 weeks ago

    Burnaby, Canada Fortinet Full time

    DescriptionThe successful candidate will join the Product Management team and specialize in Public & Private Cloud solution documentation. In this position you would be responsible for sourcing, compiling and publishing technical customer-facing content related to our public and private cloud offerings. You will interact with colleagues globally across...

  • Product Management Specialist

    4 weeks ago

    Burnaby, Canada Fortinet Full time

    DescriptionThe successful candidate will join the Product Management team and specialize in Public & Private Cloud solution documentation. In this position you would be responsible for sourcing, compiling and publishing technical customer-facing content related to our public and private cloud offerings. You will interact with colleagues globally across...