Quality Assurance Manager Jobs

An exciting opportunity for a Quality Assurance Manager, this is a permanent opportunity with Qvella Corporation located in Richmond Hill, ON.

Position Summary :

Lead the QA Operations activities to ensure timely delivery of GMP complaint IVD products to the market. Maintain and improve ISO 13485/MDSAP quality system to ensure suitability, adequacy and effectiveness in accordance with company's quality manual, procedures and applicable regulatory requirements.

Essential Duties and Responsibilities :

• Review and approve process validation protocols and reports
• Coordinate with Engineering the electrical, safety and EMC testing (IEC 61010)
• Implement, manage and maintain the equipment qualification, calibration and maintenance program; review and approve IQ/OQ/PQ
• Manage personnel training plans/matrices and ensure timely completion of training
• Maintain document control process by creating, revising, reviewing and releasing quality related documents
• Assist the Management Representative in preparation for quality system audits
• Manage and review NCRs, OOS, deviations, CAPAs, change control requests, customer complaints and ensure timely completion of related actions and reports
• Analyze data to identify areas for improvement in the quality processes
• Collaborate with other departments to improve processes, complete projects, and provide guidance in relation to quality
• Implement, review and maintain processes and documentation related to incoming, in-process, QC inspection and product release activities
• Participate in activities related to the implementation of UDI requirements
• Provide company wide training on ISO 13485, FDA QSR, revised procedures and quality matters, as required
• Lead, coordinate and conduct quality system audits and supplier audits, as planned
• QA representative in Supplier Review Board to assess, qualify and monitor suppliers
• Other duties as required

Other Job Requirements :

• May include travel, when necessary (audit)
• Excellent knowledge of ISO 13485, MDSAP and IVD medical device related standards and guidelines
• Excellent verbal communication skills in order to act as a facilitator and educator with strong leadership skills
• Understanding of 21 CFR Part 11 and Data Integrity Regulations
• Professional approach and appearance
• Working knowledge of Health Canada, EU, FDA, electrical & safety, software and MDSAP requirements pertaining to medical devices
• Knowledge of process validation requirements; protocols, testing and reports review
• Excellent written communication skills in order to draft and maintain quality related documentation

Experience/Qualifications :

• Process oriented, logical, analytical, problem solving; able to analyze data and implement solutions
• Preference will be given to candidates with certification for quality audit (CQA), quality engineer (CQE), manager of quality (CMQ/OE), Six sigma
• Minimum of 5 years’ hands-on experience in quality assurance preferably in the medical device industry, including a minimum of 2 years managing projects and/or supervising people
• Proficient computer skills including all MS Office applications
• Highly organized, meticulous and capable of multi-tasking various projects/timelines at one specific time
• Demonstrated success within a start up, entrepreneurial work environment
• Strong interpersonal skills and teamwork approach; motivated to achieve goals

Education :

• Bachelor or Master degree in science, engineering or biomedical

In support of our commitment to a healthy and safe workplace, Qvella Corporation has a vaccination requirement as a condition to the offer of employment. Fully vaccinated is defined as having received a completed series of an accepted COVID-19 vaccine, as recommended or approved by Health Canada and having received the final dose at least 14 days before your employment start date. Ongoing boosters may be required in the future as a continuing condition of employment, as they are announced by Health Canada. We will provide a full copy of our policy at the time of offer.

The candidate will be asked to provide Qvella with proof of full vaccination, prior to their employment start date. Acceptable proof is a Ministry of Health Dose Administration Receipt. This can be obtained through the Provincial portal at

The requirement to be fully vaccinated is subject to the Ontario Human Rights Code. If the candidate is unable to vaccinate for a reason protected by the Code, a request for accommodation can be made upon written proof, satisfactory to the company.

What are you waiting for? Apply Now!

Qvella is an equal opportunity employer. We are committed to a diverse and inclusive workplace for all. If you are selected to participate in the recruitment process, please inform us of any accommodations you may require. Qvella will work with you in an effort to ensure that you are able to fully participate in the process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Must be legally eligible to work in Canada at the location(s) specified above and, where applicable, must have a valid work permit or study permit that allows the candidate to fulfill the requirements of the role.

We thank all interested applicants; however, only those selected for an interview will be contacted.

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