Quality Assurance Specialist

3 weeks ago

Burnaby, Canada Kardium Inc. Full time

Your opportunity
By joining the Kardium team, you can help make a difference in the lives of millions around the world. We have developed a ground-breaking medical device for the diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation - which can cause stroke, heart failure, and other heart-related complications.
Kardium’s mission is to deliver the best treatment for atrial fibrillation. To achieve this, we have developed The Globe® Pulsed Field System - we have a fantastic technical team that has developed a product with strong, unique, and customer-valued differentiators versus other solutions on the market. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story.
We have now completed our pivotal clinical study and our focus is on regulatory approvals and commercial launch. This is an exciting and significant milestone in our journey to bring this ground-breaking technology to patients.
Kardium has a unique opportunity for an experienced Quality Assurance (QA) Specialists. As members of the QA Team, our QA Specialists provide direct QA support to the Manufacturing and Engineering teams and contribute to the continuous improvement and maintenance of Kardium’s Quality Management System (QMS).
Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.
Meaningful work you will be a part of
**Your responsibilities will include**:
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

QMS support
- 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

What you bring to the team
Our Kardium team is smart, creative, and passionate about developing cutting-edge medical devices to help improve people’s lives. We work in a collaborative environment based on trust and respect. We understand that only by working together can we solve what was thought unsolvable.
You will be successful in this role because you possess these attributes:
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

**Skills**:

- 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 mínimal 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

Compensation
As a permanent employee, you will also participate in Kardium’s stock option plan.
- $69,500 - $90,000 (CAD Annually)

Your Benefits & Well-being
Total cash - the tota

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