Quality Assurance Associate

1 month ago

Richmond, Canada bioLytical Full time

**bioLytical** is hiring an experienced Quality Assurance (QA) Associate. You are responsible for providing support to QA daily activities, namely in the areas of risk management, CAPA management and validation review. 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*
- Maintains the effectiveness of the Quality Management System (QMS) and ensures adherence with applicable international standards and regulations
- Supports the CAPA management process by ensuring investigations, root cause analysis, and corrective and/or preventive actions are performed and closed in a timely manner
- Identifies nonconformances, gaps, and/or inefficiencies in the system procedures or processes and initiates the appropriate corrective or preventive actions if required
- Reviewing customer complaints to ensure accurate documentation of investigation results within the assigned complaint records
- Reviewing validation protocols and reports
- Reporting quality metrics data & trending and identifying opportunities for improvement
- Support risk management activities, including FMEA & PFMEAs reviews
- Assist with Change Control and Document Control activities including reviewing, revising, and editing quality documents
- Assist with review of batch records to ensure compliance with procedures for incoming raw materials, in-process materials and finished goods
- Participate in management review, internal and external audits as needed
- Performing any other Quality Assurance tasks as required

**WHAT YOU WILL BRING**
- Undergraduate university degree, preferably in a scientific discipline.
- Minimum 3 years experience in a quality related position, preferable in medical device -IVD
- Preferable 2 years working experience with Medical Device Quality System regulations
- Ability to work independently.
- Self-motivated, team oriented with excellent written and verbal communication skills.
- Excellent analytical, problem-solving, and decision-making 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 #ISO14971

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