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.