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.