Quality Assurance Associate

3 weeks ago

Richmond, Canada bioLytical Full time

**bioLytical** is hiring a self-motivated Quality Assurance (QA) Associate. You are responsible for providing support to QA daily activities. You will play a vital role in driving forward our mission to get people tested with the best technology on the market, living the INSTI Core Values through and through.

*
HOW YOU WILL CONTRIBUTE*
- Provide quality assurance support to operations of the company, including review of batch records, the release of incoming raw materials, in-process materials, and finished product
- Review, follow up on root cause and corrective actions, and close Non-Conformance Reports (NCRs) and Process Deviation Reports (PDRs)
- Participate in internal and external audits based on MDSAP, medical devices/IVDD regulations
- Review Change Control reports and assist with update to quality procedures
- Assist with maintenance and monitoring of Suppliers including Supplier Corrective Action Reports (SCAR’s)
- Assist with risk management activities, reviewing FMEA & PFMEAs
- Performing any other QA tasks as required.

**WHAT YOU WILL BRING**
- Undergraduate university degree, preferably in a scientific discipline.
- Minimum 2 years’ experience in a quality related position, preferable in medical device -IVD
- Experience working with Medical Device Quality System regulations is an asset
- Ability to work independently.
- Self-motivated, team oriented with excellent written and verbal communication skills.

**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
- Full-size in-house fitness gym and shower facilities
- Complimentary reserved parking
- Opportunity to work with industry experts who are motivated and passionate about what they do but know how to have some fun
- A chance to show off your dance moves and singing voice at the company parties and jump in to score a victory or lead the way in our outdoor games at the summer barbeques
- The opportunity to join an ‘off the charts’ foodie culture in our large kitchen and try out your favourite recipes or enjoy the culinary delights as they hit the share table

**About bioLytical**

bioLytical Laboratories Inc. is a privately-owned Canadian company focused on the research, development and commercialization of rapid _in vitro_ medical diagnostics using its proprietary INSTI® technology platform. bioLytical has won several local and industry awards. We have been featured on BC’s Fastest Growing Companies four years in a row including the Globe and Mail’s Fastest Growing Companies list in 2020. We were named BC Exporter of the Year in 2019 and have been named Lifesciences BC’s Growth Stage Med Tech Company of the Year. In 2020, bioLytical moved to a significantly larger, state-of-the-art facility in Richmond to accommodate the extraordinary growth achieved through our team.

*
CORE VALUES*
- **INNOVATION** in what we do, how we do it and how we think: Contributes new ideas, challenges the status quo, takes the 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 a passion for INSTI, our people and our projects. Is not complacent, shares knowledge freely, exhibits awareness of self, their surroundings, and the business.

quality #qualityassurance #manufacturing #medicaldevice #ISO13485 #IVD

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