Quality Assurance Specialist

Quality Assurance Specialist

We have a new opportunity for a Quality Assurance Specialist to join the growing team at ViVitro Labs, an internationally recognized and growing company that provides specialized contract testing services and test equipment solutions to support medical device innovations in the cardiovascular space. This role is based in Victoria, BC.

Reporting to the President, ViVitro Labs, you will provide quality assurance support to cardiovascular testing, commercialization, and regulatory experience to every project. The Quality assurance specialist is responsible for monitoring, inspecting, and proposing appropriate measures to correct or improve the quality of the cardiovascular testing device to ensure it meets the highest quality and regulatory standards.

Are you detail-oriented, thorough, and a stickler for manufactured high-quality medical devices? If this sounds like you, and this opportunity sounds intriguing, keep reading!

RESPONSIBILITIES:

  • Ensures compliance with the ISO/IEC 17025:2017 standard and internal policies and procedures.
  • Provide leadership and support to satisfy and exceed Company, customer, industry and regulatory standards and requirements critical to the success and excellence of the business.
  • Collaborate with personnel to harmonize best practices across the organization, as applicable.
  • Schedule and perform internal quality audits and maintain internal audit schedule.
  • Maintain document control system and write a review, edit, and finalize procedures.
  • Review and approve test protocols and test reports.
  • Manage, host, and prepare individual offices for external clients or accreditation audits.
  • Monitor key performance indicators (KPIs) for effectiveness and report to management.
  • Assist in or conduct root cause analysis/investigations to resolve complaints, discrepancies, nonconformances or other concerns with risk-based corrective actions that are efficient, impactful, and sustainable.
  • Assist in the documentation and resolution of customer complaints.
  • Maintain and provide training.
  • Other duties may be assigned.

EDUCATION and EXPERIENCE:

  • Bachelor’s degree in science, engineering, or related technical discipline.
  • Three + years of related experience or training in an ISO/IEC 17025:2017 accredited quality role.
  • Experience or training in a mechanical engineering environment is an asset.

LANGUAGE AND OTHER SKILLS:

  • Ability to read and interpret documents such as methods, safety rules, operating and maintenance instructions, and procedure manuals.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
  • Ability to apply common-sense understanding to complex situations and prepare or follow instructions in written, oral, or diagrammatic form.
  • Ability to write routine reports and correspondence.
  • Ability to speak effectively before groups of employees.
  • Well organized, disciplined, and self-motivated, capable of balancing multiple priorities in a very high-paced environment.
  • Must be able to work with a diverse group of individuals performing bench testing.
  • Good listening skills are essential.
  • The ability to read, write, and speak French is an asset.

VIVITRO LABS:

ViVitro Labs provides testing services and equipment to support the continued innovation of cardiovascular devices with a focus on heart valve replacement and repair. An internationally recognized and trusted source for testing expertise, ISO:17025 certified, and with a reputable history of more than 25 years. ViVitro Labs is a small company relied upon by hundreds of organizations in over 40 countries for their consulting and custom engineering solutions to test the industry’s most advanced cardiovascular devices.

ViVitro Labs is a small, tight-knit team looking at significant international growth in the next 5 years. ViVitro Labs works closely with universities, medical device manufacturers and regulatory agencies to support their research, regulatory, and production requirements. As a heart-valve testing industry leader, ViVitro participates in several ISO working groups.

To find out more about ViVitro Labs, visit: www.ViVitroLabs.com

How To Apply:

Qualified candidates for the Quality Assurance Specialist role at ViVitro Labs are encouraged to apply through the brand new ViVitro Labs Job Portal with a resume and cover letter that clearly indicates how your education and experience meet the requirements of this position.

If you experience any difficulties with the ViVitro Labs Job Portal, please reach out to careers@starfishmedical.com with a subject line of “ViVitro Quality Assurance Specialist Job Portal Issue”.

We thank all candidates who apply; however after initial acknowledgement, only those selected for further consideration will be contacted.

Join over 5000 cardiovascular device professionals who receive our testing and engineering insights and tips every month.