Quality Systems Specialist

At Trudell Medical International, we're looking for a Quality Systems Specialist to deliver key Quality System processes, analyze current state, and implement process improvements. The role involves coordinating quality system activities, initiating and reviewing quality system documents, and maintaining departmental Key Performance Indicators (KPIs).

Requirements

• 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

Benefits

• Flexible work environment
• Respectful and family-oriented culture
• Opportunity to contribute to the development of products at the cutting edge of medical device technology
• Chance to work with a first-rate group of dedicated professionals