Quality Assurance Manager

3 days ago


Toronto, Ontario, Canada COLTENE SciCan Full time

About COLTENE SciCan

COLTENE SciCan is a global leader in the development, manufacture and sale of consumables and small-size equipment for dental treatment applications.

Job Description:

We are seeking an experienced Quality Assurance Manager to join our team. The successful candidate will be responsible for ensuring that quality standards and policies/procedures are upheld and aligned with regulations and customer specifications.

The ideal candidate will have a minimum of 5-10 years of experience dealing with quality management systems, regulations, guidelines and associated standards preferably in a Medical Device manufacturing environment. Strong communication skills are essential for liaising and communicating with suppliers, customers, auditing bodies, and internal departments.

Responsibilities:

  • SUPPLIER QUALIFICATION AND EVALUATIONS: Perform supplier qualification and evaluations (ISO certificates, quality infrastructure).
  • PRODUCT CERTIFICATION: Provide input on product certification related issues.
  • METROLOGY FOR TOOLING: Oversee metrology for all tool, jigs and fixtures.
  • CONTINUOUS IMPROVEMENT PROGRAMS: Develop and implement continual improvement programs.
  • RISK MANAGEMENT: Practical experience with risk management, product testing, capability studies, and quality plans.
  • LEADERSHIP: Provide leadership developing and directing QA/QC personnel and identify relevant training needs.
  • BUDGET MANAGEMENT: Develop and manage departmental budget
  • QUALITY AUDITS: Oversee/facilitate external audits to ISO standards, FDA Inspections, Health Canada Inspections, Foreign inspections, etc.
  • TIMELY RESOLUTION OF ISSUES: Drive manufacturing product quality through regular quality control checks and by monitoring production failures and customer complaints and engaging with R&D, Production, IE, BU, etc. to resolve issues in a timely manner.

Requirements:

  • Degree in Quality Engineering or Engineering Degree plus Quality Certificate.
  • Minimum of 5-10 years of experience dealing with quality management systems, regulations, guidelines and associated standards preferably in a Medical Device manufacturing environment.
  • Knowledge and experience in ISO 13485, MDSAP required; MDR experience is an asset.
  • Strong problem identification and problem resolution skills.
  • Able to interface directly with cross-functional teams.
  • Ability to create and review technical documentation, including project plans, test procedures, and design documents.
  • Able to develop, review, and maintain metrics and quality audits.
  • High level of proficiency with computer system; MS Office, Visio, PLM & ERP (SAP preferred).

Salary and Benefits:

We offer competitive compensation, comprehensive benefits and pension program, continuing education reimbursement program, and a fun and positive team environment. Our estimated salary range is $80,000-$120,000 per year.



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