Quality Assurance Manager

Quality Assurance Manager
Location: Richmond, BC, Canada – Head Office
Department: Quality Assurance (QA)
Position: Permanent, Full-Time
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ABOUT BIOLYTICAL

Did you know that you no longer have to book an appointment with your doctor and wait weeks to get lab results back for STIs like HIV and Syphilis?

 

bioLytical’s INSTI is the world’s fastest testing platform – providing results in just 1 minute.  Yes, you read that correctly – results in 1 minute not 1 to 2 weeks!  We’ve been in business since 2002 and have recently been growing like crazy with the launch of new products all over the world.  bioLytical Laboratories has ranked on Business in Vancouver’s Top 100 Fastest Growing Companies list two years in a row and is the winner of the 2018 Lifesciences BC’s Growth Stage MedTech Company of the Year.

 

The full suite of INSTI tests are greater than 99% accurate and have a world-wide footprint of regulatory approvals including US FDA, Health Canada, World Health Organization Prequalification and CE mark for Europe.  bioLytical markets its HIV point-of-care tests, HIV self-tests and dual HIV/Syphilis Multiplex point-of-care tests globally with a strong product pipeline from our research team.  INSTI is the world’s fastest test, which means more people tested, more people diagnosed, and more people linked to care.

 

We are looking for talented and passionate people to join us on our mission to end AIDS.  With millions of tests already sold, INSTI is trusted by healthcare professionals and recently available to consumers.  Come join us on our journey and help make a difference in the world!

 

SUMMARY

We have an exciting opening for a Quality Assurance Manager at bioLytical. Reporting directly to the VP, Quality and Regulatory, you are responsible for leading and managing bioLytical’s Quality team along with the Quality Management System (QMS) to not only ensure compliance with statutory and regulatory requirements but actual efficiency.

 

The QA Manager requires the ability to analyze complex technical and medical information for problem solving and ability to liaise confidently with Auditing Organizations such as the US FDA, Health Canada and other International Health Authorities.

 

You will develop and coordinate system-wide processes and activities to optimize efforts in quality and continuous improvement.  You will have oversight and accountability for continual best practices in accreditation, risk management, compliance and safety.  You will foster and maintain collaborative relationships with external agencies, suppliers and stakeholders related to quality/performance initiatives.

 

You live the INSTI Core Values through and through and play a vital role in driving forward our mission to get people tested with the best technology on the market.

 

INSTI CORE VALUES 

  • INNOVATION in what we do, how we do it and how we think: Contributes new ideas, challenges the status quo, takes initiative on projects.
  • NEVER SAY NEVER: Stays engaged until the goal is reached or project is completed. Overcomes barriers. Cares so much about the task at hand that the impossible is made possible.
  • SENSATIONAL to our clients, to our partners, to each other: Spirited team player, who adapts to new situations quickly and is beyond reliable.
  • TAKES OWNERSHIP of goals, decisions, actions and results: Arrives on time and prepared, leads by example, follows through on commitments.
  • INSPIRED TO EXCEL: Demonstrates passion for INSTI, our people and our projects. Is not complacent, shares knowledge freely, exhibits awareness of self, their surroundings and the business.

 

HOW YOU WILL CONTRIBUTE

Your past validates that “Quality cannot be inspected into a product or service; it must be built into it.” and you have many real-world examples to share of how you’ve implemented systems to control upstream process.

  • Lead the QA department and act as Management Representative for the QMS during third party audits and inspections
  • Plan and coordinate implementation of a digital QMS complaint with the US FDA and European requirements
  • Mentor and manage performance of QA personnel
  • Manage the daily operations and maintenance of QMS
  • Continually monitor and improve the QMS as well as support the continuous improvement of operations and business systems
  • Analyze statistical data to determine trends and implement corrective actions as required
  • Support Manufacturing with development of equipment and process FMEA and implementation of manufacturing controls
  • Assist Research and Development during product development with risk management and design transfer to manufacturing
  • Support Supply Chain with supplier evaluation, monitoring and auditing
  • Provide guidance on quality assurance for product development and manufacturing optimization projects
  • Lead the internal audit program and second party audits
  • Implement and monitor (leading not lagging) Quality Key Performance Indicators
  • Develop plans and implement actions to ensure the manufacturing facility operates in conformity with statutory and regulatory expectations and maintain readiness for third party inspections and audits
  • Update Executive Management during weekly meetings on the performance of the QMS and/or product, processes and system risks
  • Develop and manage the budget and staffing requirements for the QA Department

 

WHAT YOU BRING

  • Bachelor or master’s degree in a scientific or engineering discipline, or equivalent combination of education and experience
  • A minimum of 10 years of work experience managing quality system operations in a manufacturing environment in the medical device or pharmaceutical industry
  • Managerial experience including direct supervisory experience and experience building and meeting budgets and timelines
  • In-depth knowledge of Canadian, US and European regulations, ISO 13485 and ISO 14971
  • Understands lean manufacturing methodologies
  • Experience using quality and management tools for process improvement and cost reduction
  • Experience with audits in the medical devices and in-vitro diagnostics industry
  • Experience working with an electronic QMS considered an asset

 

WHAT WE OFFER

  • A competitive compensation package
  • Extended health benefits including dental – 100% employer contribution
  • Flexible working hours
  • Paid sick days
  • Bonus day off with pay on your birthday every year!
  • Complimentary reserved parking
  • Complimentary shuttle to/from the office and River Rock Hotel
  • Exercise room with a gym and shower facilities
  • Opportunity to work with industry experts who are motivated and passionate about what they do but know how to have some fun
  • Oh and you will also have a chance to show off your dance moves and singing voice at the Christmas parties, lead in lawn bowling or volleyball at the summer barbeques and devour cake at the monthly birthday celebrations

 

HOW TO APPLY

BioLytical Laboratories Inc. offers a challenging, enriching work environment. To apply for this opportunity, please send your resume and cover letter with salary expectations to  careers@biolytical.com.

We are an equal opportunity employer and invite applications from all qualified individuals.

Contact Info

Headquarters
1108-13351 Commerce Parkway
Richmond, BC V6V 2X7
US Address
1465 Slater Road
PO Box 5007
Ferndale WA 98248-5007
info@biolytical.com
1.866.674.6784
604.204.6784
604.244.8399
www.biolytical.com
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