Quality Assurance Manager
City: Richmond, BC, Canada
Department: Quality Assurance (QA)
Position: Permanent, Full Time
bioLytical is hiring!!!
Do you think outside-of-the box while ensuring compliance to regulations?
Does innovation and expansion excite you?
Do you see possibilities in challenges?
If this is you, then read on. We are interested in speaking with you!
bioLytical Laboratories is one of BC’s fastest 100 growing companies and is hiring a Quality Assurance Manager. Based in Richmond, BC, Canada, we are a privately-owned Canadian company focused on research, development and commercialization of rapid, point-of-care and home-use/self-test in-vitro diagnostic devices using our proprietary INSTI technology platform.
With a world-wide footprint of regulatory approvals including US FDA, Health Canada and CE mark approvals, we market and sell the INSTI HIV test to 60 countries globally and the INSTI HIV/Syphilis Multiplex test within Europe. With INSTI we provide highly accurate test results in less than 1 minute, much faster than the 15-20 minutes required for tests based on lateral flow technology.
We have an exciting and challenging opening for a Quality Assurance Manager at bioLytical’s head office in Richmond, BC. Reporting directly to the Senior Director of Operations, 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.
Ages ago, you lived and breathed paper-based systems full of spreadsheets and word docs but in the last few years you graduated up to the digital world and have implemented a digitized QMS that is effortlessly efficient.
If you have to google MDSAP, then this position is not for you. You know that the MDSAP requirements are newer but you’ve already created transition plans and prepared for the audit(s) and can do that again swiftly.
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.
You are a natural mentor to both experienced and up and coming QA team members and a wonderful peer coach to others on the management team. You live the INSTI core values through and through:
- 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:
- 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, optometry, RMT, etc.
- Flexible working hours
- Paid vacation (plus you get a bonus day off WITH pay on your birthday every year!)
- Paid sick days
- A complimentary reserved parking spot
- Complimentary shuttle to/from the office and River Rock Hotel
- 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:
Send your cover letter and resume to email@example.com or send us an email if you need additional details about this opportunity.
We are an equal opportunity employer and invite applications from all qualified individuals.