Qvella Corporation Looking for Manager, Quality Assurance at Ontario Full Time

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:

• Implement, review and maintain processes and documentation related to incoming, in-process, QC inspection and product release activities

• Manage and review NCRs, OOS, deviations, CAPAs, change control requests, customer complaints and ensure timely completion of related actions and reports

• Implement, manage and maintain the equipment qualification, calibration and maintenance program; review and approve IQ/OQ/PQ

• Coordinate with Engineering the electrical, safety and EMC testing (IEC 61010)

• QA representative in Supplier Review Board to assess, qualify and monitor suppliers

• Review and approve process validation protocols and reports

• Participate in activities related to the implementation of UDI requirements

• Maintain document control process by creating, revising, reviewing and releasing quality related documents

• Lead, coordinate and conduct quality system audits and supplier audits, as planned

• Manage personnel training plans/matrices and ensure timely completion of training

• Provide company wide training on ISO 13485, FDA QSR, revised procedures and quality matters, as required

• Analyze data to identify areas for improvement in the quality processes

• Assist the Management Representative in preparation for quality system audits

• Collaborate with other departments to improve processes, complete projects, and provide guidance in relation to quality

• Other duties as required

Other Job Requirements:

• 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

• Excellent written communication skills in order to draft and maintain quality related documentation

• Working knowledge of Health Canada, EU, FDA, electrical & safety, software and MDSAP requirements pertaining to medical devices

• Understanding of 21 CFR Part 11 and Data Integrity Regulations

• Knowledge of process validation requirements; protocols, testing and reports review  

• Professional approach and appearance

• May include travel, when necessary (audit)

Experience/Qualifications:

• 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

• Demonstrated success within a start up, entrepreneurial work environment

• Highly organized, meticulous and capable of multi-tasking various projects/timelines at one specific time

• Proficient computer skills including all MS Office applications

• Process oriented, logical, analytical, problem solving; able to analyze data and implement solutions

• Strong interpersonal skills and teamwork approach; motivated to achieve goals

• Preference will be given to candidates with certification for quality audit (CQA), quality engineer (CQE), manager of quality (CMQ/OE), Six sigma

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 https://covid19.ontariohealth.ca/.   We will also accept out of province vaccination records, provided they have the same information included in the Ministry of Health Dose Administration Receipt.  This includes the type of vaccine, date of each dose and sufficient identification information to connect the receipt to the candidate. 

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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