We are currently hiring:
Sr. Quality Assurance Associate
We are currently seeking a motivated, energetic and results oriented Sr. Quality Assurance Associate to join our Mississauga Head Office.
If you feel under-challenged in your current role, or you have the education but now want to start your career in a laboratory/healthcare environment, and are the type to jump at an opportunity to join a team that loves what they do, takes pride in how they do it, and cares about those people they do it with, we think you can be successful at Covalon.
Covalon is a Canadian public medical technologies company facing significant growth opportunities and change. We are currently engaged in one of the fastest growing markets; Healthcare. We specialize in research, development, and commercialization of advanced tissue repair applications, infection control, and specialized coatings for medical and consumer products. We offer a unique work style and culture fueled by passion, innovation, accountability and a commitment to give customers more.
As a Senior Quality Assurance Associate, you will be an integral contributor to a dynamic, cross-functional team of technical, clinical, QA/RA, and marketing individuals devoted to developing advanced wound care and infection control product.
Day to day duties will include developing and maintaining Quality System procedures that are in compliance with ISO 13485, FDA, MDD, MDSAP requirements, as well as representing QA when collaborating closely as with personnel in other functional units and in Project Teams.
Drive CAPA, non-conformance and complaint investigations, including root cause analysis, corrective/preventative action implementation and effective checks.
Prepare and/or review draft SOPs/Quality Records/protocols/reports as needed.
Actively participate in addressing CAPAs and coordinating CAPA review meetings.
Participate in investigation and resolution of complaints and non-conformances.
Coordinate and conduct internal and supplier audits.
Assist with management of suppliers, including qualification and auditing.
Create and review validation protocol and report, including manufacturing process, packaging process, sterilization process and stability program.
Provide QA input in project team meetings, design reviews and risk management meetings.
Provide input and assist in process validation activities and documentation
Review documents required to release raw materials, packaging materials, in-process and finished product.
Develop training materials and conduct quality system training on key subsystems.
Facilitate and implement changes and improvements to the quality system to ensure the effective and efficient operation of the quality system.
Collect and analyze data with statistical techniques from quality processes and generate regular reports.
B.Sc. or equivalent undergraduate degree in a scientific area.
In depth knowledge ISO 13485:2016, 21 CFR 820, and ISO 14971.
Working experience in implementation of MDSAP and ISO 13485:2016 compliant quality system.
Minimum of 3 years or more experience in a FDA QSR and/or ISO 13485-compliant environment.
Certified quality system auditor.
Knowledge and experience on medical device sterilization process is a credit.
Ability to prioritize multiple tasks.
Excellent written/oral communication and organizational skills.
Strong problem solving and analytical skills.
Knowledge and application of Microsoft Office for word processing, reporting and data analysis.
Exceptional problem-solving skills and ability to “think outside the box”.
Capable of applying regulations and requirements.
Ability to work autonomously.
Self-motivated and self-directed.
Adaptable and willing to take on multiple new tasks and responsibilities.
Ability to work independently as well as participating in a team of professionals.
Ability to respond to urgent situations appropriately by prioritization.
Ability to leverage relationships across other business units and with external sources.
Ability to follow-up with individuals without guidance.
Accuracy and strong attention to detail is essential.
Your salary will be market competitive and commensurate with your experience and expectations. We have an excellent benefit package that includes medical, dental, life, and more. Opportunities for participation in individual and corporate bonus plans and our stock option plan can make for a lucrative upside to your remuneration.
If you are the right person for us and you think we may be the right people for you, please apply, including your cover letter telling us why you’d be perfect for this career opportunity!
Covalon is compliant with the Ontarians with Disabilities Act. If you have a disability, please let us know how we can accommodate you.
Please e-mail HR@covalon.com with Sr. Quality Assurance Associate in the subject line.