Quality Assurance Specialist

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.