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Site Lead Auditor - Quality

Job Title: Site Lead Auditor - Quality
Contract Type: Permanent
Location: Canada
REF: 97037
Job Published: about 2 months ago

Job Description

Contact: Bimi Felix
Telephone: 086 8395533

Site Lead Auditor - Quality

Our client, a medical device company in Canada is currently looking to recruit a Site Lead Auditor for their site.

Role Summary
The Site Lead Auditor is a fully trained leader in quality assurance techniques (investigational, statistical and analytical) with experience and qualifications as a Facility Lead Auditor. They are the technical guides to navigating the Quality Management Systems and its conformity to ISO 13485 and various governmental regulatory requirements especially as it relates to document control, customer complaints, corrective and prevent action, measurement and feedback and statistical techniques. Ideal candidate has a keen understanding of ISO standards and methods of failure and risk analysis.

Snapshot of Responsibilities
  • Ensure the adequacy of, manage and coordinate the internal audit system, including development of the internal audit plan, internal audit schedule and assigning auditors per the plan training of new auditors review and approval of internal audit checklists and reports updating the internal audit system as necessary
  • Manage and coordinate the control and implementation of standards across the organization
  • Initiate, coordinate and analyze (e.g. Root cause analysis, trending, control charting, gap analysis) data and reports using statistical techniques; Analyze and interpret standards and regulations and makes recommendations for changes based on requirements and specifications
  • Review and approve records, reports and data; Directs and initiates changes as a result of the data
  • Make independent studies, analyses, interpretations and conclusions based on sound statistical reasoning
  • Participate in supplier audits as an audit team leader
  • Responsible for planning, implementation and effectiveness of significant improvement activities
  • Comply with the Health & Safety policies of the company and inform management of unsafe working conditions

Other duties
  • What you bring to the team
  • Bachelor's Degree in Engineering or related field of Science required
  • Training or certification as a lead auditor by an accredited institution required
  • 3-5 years quality assurance/ quality engineering experience preferred, in medical device or pharmaceutical industry
  • Excellent analytical and communication skills (presentation, written and oral)

What we have to offer
  • Opportunity for growth
  • Competitive salary and benefits
  • RRSP matching
  • Flexible start times
  • On site gym facility

For further information on this Site Lead Auditor role in Canada please contact Bimi on 086 8395531 /

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