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Quality Assurance Specialist Jobs
Company | Kardium Inc. |
Address | Burnaby, British Columbia, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Medical Equipment Manufacturing |
Expires | 2023-05-19 |
Posted at | 1 year ago |
Your opportunity
- Perform QA review of Device History Records (DHRs) to support finished goods release
- Assist with root cause investigation (e.g. targeted DHR review)
- Conduct the QA review of equipment documentation, including but not limited to qualification, maintenance, and calibration records
- Perform QA review of production documentation associated with quality issues, including deviations, nonconformities, discrepancies, and reworks
- Conduct the QA review of production Device Master Record documentation, including work instructions and traveller templates
- Review and execute the QA release of incoming materials and in-process goods
- Participate in the QA coordination of change control activities
- Provide QA input into process validation activities
- Review verification and validation documentation, including but not limited to test plans and reports for equipment qualification, process validation, engineering studies, design verification, engineering change requests, etc.
- Conduct the QA review of software tool implementation and validation documentation, such as requirements documents, validation plans, test protocols, test reports, etc.
- Oversee and manage various QMS project activities assigned to QA
- Perform document control tasks such as assuring that the review and approval of controlled documents is in accordance with Kardium policies and procedures, and maintaining quality records per established procedures
- Participate in Kardium’s internal audit program as needed
- Perform other QA tasks as required
- Bachelor of science degree in a technical discipline (e.g., engineering, pharmaceutical sciences, biotechnology, etc.)
- At least 3 years’ QA experience in a manufacturing environment in the biotechnology industry; experience in QMS planning and implementation an asset
- Strong, in-depth, working knowledge of ISO 13485, FDA QSR and QMS requirements of the European MDD; organizational awareness of quality management system implementation and operations
- Thorough knowledge of documentation and record control systems; experience with electronic document and electronic record management systems an asset
- High proficiency in MS Word/Excel an asset
- Flexible and adaptable to take on additional responsibilities as appropriate
- Work efficiently with the ability to be innovate and identify creative solutions
- Excellent interpersonal skills including the ability to resolve conflict with poise, diplomacy, and tact
- Ability to work effectively as part of a team and collaborate with staff at all levels
- Complete multiple tasks in a timely and thorough manner (i.e. organized and detail-oriented)
- Effective written and verbal communication and technical documentation skills
- Strong analytical skills and critical thinking
- Able to operate independently with minimal direction
- Opportunity to extend your knowledge by interacting with other team members in a multi-disciplinary environment that includes electrical and mechanical engineers, biologists, and specialists in human factors, and clinical and regulatory affairs
- Knowing every day that you are making a difference in people’s lives by helping treat a condition that debilitates millions worldwide
- Supportive and fun colleagues with plenty of social events to encourage people connections
- A great working environment with opportunities to develop your skills and knowledge
- An engaged leadership team who believes in mentoring and growing employees’ careers
- And our employees think we are great too – check out Glassdoor to learn more!
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