Tagline: Ensure safe and effective products at a fast growing medical technology company!
Type of Position: Full time
Location: Kitchener HQ, 809 Wellington St. N.
The Quality Assurance Analyst will join a fast growing medical technology company in a position that supports design, production and process quality. You will contribute to the maintenance of the quality system ensuring compliance to industry standards and regulatory requirements. You will also ensure that products are safe and effective.
As a snapshot, we are looking for someone who:
- Possesses quality management experience in a regulated working environment
- Is able to take a problem, identify the root cause and develop a solution relating to the quality of products
- Has experience supporting the design, development and production of novel technology
Expectations and Employee Experience
- It is unrealistic for us to believe we will find someone who fits this position 100%
- Be ready to be innovative!
- Be passionate about growth, personally and professionally and know that we will support you along the way
- Work hard each day and be rewarded for that hard work
- Embrace change, this will happen as we scale but should be seen as exciting and something you want
- Flexibility so that you can do your best both at work and outside of it
- Review, analyze and report on quality issues and propose disposition and corrective actions for recurring discrepancies
- Support quality assurance activities related to audits, training, change control, document and record management
- Prepare periodic reports to support the Quality Management System
- Analyze sources of quality data to identify problem trends and opportunities for improvement
- Assist in the maintenance, approval and creation of quality documentation
- Represent quality in product development initiatives (e.g. New Product Development, Verification/Validation, Sustaining Engineering, etc.)
- Support planning and execution of design control deliverables
- Maintain the content of the Design History File to regulatory and customer requirements
- Review and approve product records for release (in-process/final) according to defined requirements and specifications
- Inspect products for acceptance according to material specifications
- Participate in the development of new medical device technologies, understanding how we can meet all required quality and regulation requirements with a newly defined process.
Skills and Experience to Enable Success:
- Post-Graduate diploma in Quality Assurance is an asset
- 3+ years of relevant quality management experience in a regulated industry
- Familiarity with US, Canada and International Medical Device Regulations
- Working knowledge of root cause analysis tools
- Knowledge of Medical Device standards (ISO 13485, ISO 14971, IEC 60601)
- Experience working with software and/or electromechanical products
- Immense attention to detail – you work in quality after all!