Quality Systems Specialist

About the job

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 Systems Specialist

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)

• 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
   

• 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
   

• Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.
   

• 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