Facility Lead Auditor - Medical Devices
Baylis Medical is a leading developer, manufacturer and supplier of high-technology medical devices for cardiology, radiology and spine products. Baylis Medical products are marketed in over 65 countries. Our goal is to conceive, develop, manufacture, and sell state-of-the-art medical products that will improve the lives of people around the world. To assist us in realizing our goal, Baylis Medical adheres to four main guiding principles: Technological Leadership, Employee Development, Customer Service and Corporate Social Responsibility.
The Facility 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 as required
- 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)
- Opportunity for growth
- Competitive salary and benefits
- RRSP matching
- Flexible start times
- On site gym facility
Baylis Medical is an equal opportunity employer and encourages applications from all qualified individuals. Please inform us if you require any accommodations during the recruitment process.
While we thank all applicants, only those being considered for an interview will be contacted.
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Linus and his team develop new medical devices, overseeing and reviewing the technical challenges involved while also communicating with other departments in order to get products to market.
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