Quality Improvement Lead

3 days ago

Burnaby, Canada Kardium 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 mínimally invasive diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation. Atrial fibrillation can cause stroke, heart failure, and other heart-related complications.

Kardium has a fantastic technical team that has developed a product with strong, unique and customer-valued differentiators versus other solutions on the market: The Globe® Pulsed Field System. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story.

Kardium has a unique opportunity for a Quality Improvement Lead. As a member of the Quality Assurance (QA) Team, the Quality Improvement Lead will provide support to the maintenance and improvement of Kardium's Quality Management System (QMS). The position reports to the Compliance Manager.

**What you'll be doing**

Your responsibilities will include:

- Identify potential quality improvement projects based on audit findings and feedback
- Analyse quality processes to look for potential improvements using lean six sigma tools
- Propose projects and prioritize based on quality objectives and cost-benefit analyses
- Works with stakeholders to formulate solutions to quality improvement initiatives
- Lead quality process improvement projects following six sigma methodology including defining, planning, implementing and reporting
- Act as process improvement facilitator and provide training to personnel on process improvement and lean techniques and tools
- Develops and assesses QMS performance metrics
- Fosters a quality improvement culture

As a member of the Compliance Team, the Quality Improvement Lead will also perform other tasks, as needed, including:

- Assist with external audits and regulatory inspections
- Act as a member of the internal audit team performing audits of the QMS, including assisting with planning, preparing reports, and other audit documentation, and performing follow-up activities
- Perform supplier qualification and monitoring activities, including site audits
- Perform assessment of investigations, corrective and preventative actions, and effectiveness checks, as needed
- Assistance with the development and delivery of QMS training
- Perform any 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 are suited to our approach and possess these attributes:
**Education and Experience**
- Bachelor's degree, preferably in a technical/science field, or equivalent combination of education and experience
- A minimum of five years experience in QA in a manufacturing environment
- Strong working knowledge of ISO 13485 and FDA QSR or ISO 9001 in a regulated industry
- Experience in lean six sigma techniques and successful project implementation. Certification such as ASQ CCSSBB or lean credentials are an asset
- Experience with electronic document and electronic record management systems
- Previous experience in auditing techniques desirable

**Skills**
- Strong analytical skills and critical thinking
- Effective written and verbal communication and technical documentation skills
- Strong computer skills (MS Office, Access, Excel)
- Organized and detail-oriented
- Excellent interpersonal skills
- Willingness to travel occasionally
- Flexible and adaptable to take on additional responsibilities as appropriate

**Why work at Kardium**

A meaningful career working with a truly innovative technology and an ambitious team, combined with:

- Knowing every day that you are making a difference in people's lives by helping treat a condition that debilitates millions worldwide
- A great working environment with opportunities to develop your skills and knowledge
- 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
- An engaged leadership team who believes in mentoring and growing employees' careers
- Supportive and fun colleagues with plenty of social events to encourage people connections
- And our employees think we are great too - check out Glassdoor to learn more***

Thanks in advance for your interest in Kardium

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