Quality Assurance Manager - Richmond Hill, Canada - Qvella Corporation

Description

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, inprocess, 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' handson 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 multitasking 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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