Kardium has a unique opportunity for an experienced Quality Assurance (QA) Specialist. As a member of the QA team, the QA Specialist will provide direct QA support to the Manufacturing and Engineering teams, and to the continuous improvement and maintenance of Kardium’s Quality Management System (QMS).
QA support to Manufacturing team:
- Conduct the QA review of production Device Master Record documentation, including work instructions and traveller templates
- Perform QA review of production documentation associated with quality issues, including deviations, nonconformities, discrepancies, and reworks
- Perform QA review of Device History Records (DHRs) to support finished goods release
- Review and execute the QA release of incoming materials and in-process goods
- 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
QA support to Engineering team:
- 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.
- Provide QA input into process validation activities
- Conduct the QA review of software tool implementation and validation documentation, such as requirements documents, validation plans, test protocols, test reports, etc.
- Participate in the QA coordination of change control activities
- Participate in Kardium’s internal audit program as needed
- 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
- Perform other QA tasks as required
Education & Experience
- 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
- Strong analytical skills and critical thinking
- Effective written and verbal communication and technical documentation skills
- High proficiency in MS Word/Excel an asset
- Able to operate independently with minimal direction
- Work efficiently with the ability to be innovate and identify creative solutions
- Complete multiple tasks in a timely and thorough manner (i.e. organized and detail-oriented)
- 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
- Flexible and adaptable to take on additional responsibilities as appropriate
How to Apply
If this position appeals to, apply today by sending your résumé and cover letter to jobs@kardium, with the job title “313 Quality Assurance Specialist” in the email subject line.