Quality Assurance Manager

1 month ago

Richmond Hill, Canada Qvella Corporation 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
- Process oriented, logical, analytical, problem solving; able to analyze data and implement solutions
- 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.

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

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