Senior Quality Assurance Director

7 hours ago

Toronto, Ontario, Canada COLTENE SciCan Full time

Job Summary:

We are seeking a highly skilled Senior Quality Assurance Director to join our team at COLTENE SciCan. As a key member of our organization, you will be responsible for ensuring the highest quality standards in our products and processes.

About Us:

COLTENE SciCan is a leading global company in the development, manufacture, and sale of consumables and small-size equipment for dental treatment applications. We value innovation, quality, and customer satisfaction, and we are committed to delivering exceptional results.

Key Responsibilities:

  • Develop and implement quality management systems and policies that meet regulatory requirements and customer specifications
  • Lead the Quality Assurance department and oversee the implementation of quality control measures
  • Collaborate with cross-functional teams to drive process improvements and ensure product quality
  • Manage supplier qualifications and evaluations, as well as provide input to design and development activities
  • Perform statistical analysis of products and services, and assess and test parts returned from the field to determine/validate defect types
  • Drive manufacturing product quality through regular quality control checks and by monitoring production failures and customer complaints
  • Coordinate root cause analysis (RCA) meetings with team members and identify and implement solutions
  • Oversee metrology for all tool, jigs, and fixtures, and develop and implement continual improvement programs
  • Maintain SciCan's ISO 13485 certification and other required standards
  • Review and approve internal audits, CAPA's, and technical files to ensure adherence to ISO 13485 requirements
  • Chair yearly QMS Management Review and drive quality awareness program through company-wide training

Requirements:

  • Master's degree in Quality Engineering or related field, plus a minimum of 5-10 years of experience dealing with quality management systems, regulations, guidelines, and associated standards
  • Knowledge and experience in ISO 13485, MDSAP, and MDR required; additional certifications a plus
  • Proven ability to deliver presentations and training effectively, and excellent communication skills for liaising and communicating with suppliers, customers, auditing bodies, and internal departments
  • Highly motivated and self-directed, capable of multi-tasking, and able to work with minimal supervision
  • Strong problem identification and problem resolution skills, and high level of proficiency with computer systems; MS Office, Visio, PLM, and ERP (SAP preferred)

Compensation:

We offer a competitive salary range of $120,000 - $160,000 per year, comprehensive benefits package, continuing education reimbursement program, and a fun and positive team environment.

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