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Quality Assurance Engineer (Manufacturing)

Position overview

This position will have the knowledge to identify gaps, develop and maintain the Merrithew Quality Management System for our manufacturing location based in Scarborough. In addition to this, the Quality Assurance Engineer monitors and maintains an internal scorecard of plant performance, and takes a lead role in auditing various management systems.

Major responsibilities

  • Coordinate activities for the Quality Management System (QMS) including but not limited to policy creation and maintenance, program roll out, documentation, training and communication
  • Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining QMS improvements; implementing change
  • In depth understanding of a Quality Management System and requirements of ISO 13485, Quality System Regulations, and preferably EU Medical Devices Regulations
  • Ensuring that CE marked devices are labeled and documented as per MDR 2017/745
  • Working with, leading and overseeing internal inspection resources, inspect incoming materials and parts by performing fit and finish inspections onsite, as well as at various suppliers across the GTA as required
  • Reject and arrange return of non-conforming and defective products based on conformance with Merrithew’s quality standards, approved customer samples, written specifications and production drawings
  • Conduct and lead audits to ensure QMS is functioning as required
  • Tracking of Key Performance Indicators (KPI) and post weekly pareto charts to KPI board
  • Drive the root-cause analysis for quality related issues; prepare documentation/reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, re-validations; evaluate problems and make recommendations for corrective action
  • Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures and creating Standard Operating Procedures
  • Tests, inspects, audits products, packaging, material and processes at various stages of the production cycle
  • Participates in sample sign-offs with high responsibility to validate product compliance to customer expectations, fit and function and manufacturability
  • Look for and analyze trends for issues
  • Other duties as assigned

Skills and qualifications

  • Post-Secondary education with an emphasis on quality management
  • 5 years’ experience in Quality Assurance in a mechanical manufacturing and assembly environment preferably in a medical device field
  • A self-starter who has the ability to work independently, identify any QMS gaps and manage priorities
  • Experience using basic measurement tools (e.g. micrometers, vernier calipers, surface gauges, etc.)
  • Previous experience leading and managing others in a team based environment
  • Quality certification considered an asset (e.g. CQE)
  • Intermediate computer skills, including Word, Excel, Power Point; experience in the preparation of charts and graphs
  • Experience working in a quality systems environment (e.g. deviations, CAPA, Engineering Change Control, SOPs)
  • Excellent time and project management skills with a high attention to detail
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Please note

  • Note to Recruiters : Thank you for your interest, but please do not contact us
  • At the present time, we will only consider those applicants who are legally authorized to work in Canada
  • A complete job description will be provided upon request

Merrithew® is committed to providing accessible employment practices that comply with the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation during any stage of the recruitment and selection process, please indicate so by notifying Human Resources.

About Merrithew®

Merrithew, Leaders in Mindful Movement, was co-founded by Lindsay and Moira Merrithew in 1988. For over 30 years they have been dedicated to enriching the lives of others by providing responsible exercise modalities and innovative fitness brands across the globe. Merrithew’s premier Pilates brand, STOTT PILATES®, delivers best-in class Pilates education and media to everyone from avid exercisers, elite athletes, and pre/post-natal clients, to rehab and fitness professionals, and is used by studios worldwide.

Other high-end Merrithew fitness brands include ZEN•GA®, Total Barre®, CORE Athletic Conditioning & Performance Training and Halo® Training. Merrithew has trained over 65,000 students in over 135 countries. Merrithew’s Media Division (MMD) produces print and video-based content for professional and consumer markets.