Quality Assurance Specialist

Job summary

Analyze and improve key quality system processes, investigate and resolve non-conformances and temporary deviations, and coordinate quality activities including document and Device History Record reviews. Analyze and report quality data and KPIs, support part approvals and audits, and contribute to departmental improvement initiatives.

Job details

At Trudell Medical International (TMI), we pride ourselves on our passion for finding innovative and creative solutions which has enabled us to develop medical devices that continue to make a difference in the lives of people around the world. Situated within a modern facility located in beautiful London, Ontario, TMI offers a comfortable work environment with a respectful and family-oriented culture. As an employee of Trudell Medical International, not only will you contribute to the development of products at the cutting edge of medical device technology, but you will also have the opportunity to perform challenging work alongside a first-rate group of dedicated professionals. We’re actively searching for our next team member for the position of: Quality ASSURANCE Specialist 16-month contract Job Purpose Strive for excellence in delivering key Quality System processes by analyzing the current state, conducting process data analysis and process improvements, and coordinating/performing quality system activities to advance and meet completion targets. This role will also initiate and review quality system documents/records and maintain, monitor, and report on departmental Key Performance Indicators (KPIs). Responsibilities Include Quality Processes and Related Activities Perform analysis and develop process improvements of the key Quality System Processes: Incoming, in-process and final inspection process The NCR process The CAR/CAPA process Device History Records Direct investigation activity related to product and processes, such as; non-conformance reports (NCRs), temporary deviations (TDs), and related corrective and preventative action (CARs/CAPAs) Lead documentation and resolution of non-conformance reports (NCRs) and temporary deviations (TDs) Data Analysis Develop and distribute reports on Inspections, NCR, TDs, and CARs, as required Develop and distribute reports on key QMS processes KPIs, as required Work with the Business and Partners to evolve the data management strategy and integration with Operations Analyze data using quality tools and practices Departmental Support Facilitate the part approval process-related activities (e.g. PPAP, supplier tooling changes, etc.) by effectively designing appropriate structures to ensure timely departmental outputs are achieved Proactively provide suggestions and participate in improvement activities Perform back up review and approval of DHRs Participate in internal audits as required by auditing, reporting, and issuing corrective actions health & Safety Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc. Qualifications Degree or diploma in Engineering (biomedical, electrical, mechanical, industrial) or a related field of study 5+ years’ experience in a quality system, process improvement, or medical device manufacturing environment 1-2 years of project management or related experience Certification in Quality discipline (e.g. CQE, CQA, CMQ) is an asset Certified as C.E.T. or Professional Engineer (P.Eng.) designation is an asset Experience working in a fast paced, result oriented team environment Knowledge and experience in an ISO 13485/MDSAP quality system program Knowledge of Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDP) Experience with quality process implementations in an eQMS system Advanced use of MS Office and Project Management Productivity tools Proven ability to analyze, develop, improve and implement quality processes Internal Audit/ISO 13485 Audit Certification is an asset Ability to handle multiple projects with excellent follow up skills Excellent analytical skills, with general knowledge of statistical and quality tools Effective collaboration and good interpersonal skills Excellent oral and written communication skills Ability to work independently Excellent organizational skills, especially in completing accurate and legible reports Excellent attention to detail At an applicant’s request, TMI will make accommodation to its recruitment process to meet the needs of applicants with disabilities. Trudell Medical International is committed to providing fair and equitable compensation opportunities to all teammates. The range displayed on each job posting reflects the target for new hire salaries for the advertised position. Within the range, individual compensation is determined by job-related skills and knowledge, relevant professional, lived experience, and/or work location. Our compensation policies and practices are designed to allow our colleagues’ growth and salary progression as they develop in their role. As a candidate, you are encouraged to ask compensation-related questions and have an open dialogue with your recruiter, who can provide specific details for this role and share more information about our total rewards package. As part of our recruitment process, we may use AI tools to screen applicants and assist in evaluating candidate qualifications. All final hiring decisions are made by our recruitment team. We are an equal opportunity employer and it is important to our Company that all its employees, including those with disabilities, find our workplace to be welcoming and supportive. If you are a candidate with a disability who requires accommodations during the recruitment process, please let us know.

What you’ll do

Analyze and improve key quality system processes, investigate and resolve non-conformances and temporary deviations, and coordinate quality activities including document and Device History Record reviews. Analyze and report quality data and KPIs, support part approvals and audits, and contribute to departmental improvement initiatives.

Requirements

Requires a degree or diploma in engineering or a related field and at least five years of experience in quality systems, process improvement, or medical device manufacturing, with one to two years of project management or related experience. Candidates should have ISO 13485/MDSAP and GMP/GDP knowledge, strong analytical and communication skills, and the ability to manage multiple projects; quality, engineering, and audit certifications are assets.

Listed skills

• Data analysis · Preferred
• Project management · Preferred
• Cross-Functional Collaboration · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Quality System Process Improvement
• Non-Conformance Management
• Corrective and Preventive Actions
• Data Analysis
• Quality Reporting
• Medical Device Quality Systems
• ISO 13485
• MDSAP
• Good Manufacturing Practices
• Good Documentation Practices
• Electronic Quality Management Systems
• Internal Auditing
• Project Management
• Statistical and Quality Tools
• Process Implementation
• Cross-Functional Collaboration

Job areas

• Manufacturing
• Engineering
• Healthcare
• Data & Analytics
• Management & Leadership

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