410 Quality Engineer – Clinical
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 minimally 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.
In this role, you will work closely with the Engineering, Manufacturing and Clinical teams to ensure that Kardium’s cutting-edge medical devices meet high-quality standards. We’re seeking a strong technical contributor who can identify key opportunities for product quality improvement, launch quality engineering initiatives, lead projects to implement these initiatives, and serve as an expert consultant to help solve technically challenged quality problems.
What you’ll be doing
Your responsibilities will be to:
- Triage all observations and issues related to the Globe product and procedure that are reported during use in the field
- Coordinate testing and inspection of the devices returned form the field for further investigation
- Perform preliminary investigations of product issues reported from the field and work with subject matter experts in root-cause analysis and recommend potential corrective and preventive actions
- Complete and track all internal documentation for investigations and corrective actions for reported field issues
- Identify trends, and provide solutions for corrections and improvements to process controls
- Develop a robust feedback in-take system for reporting observations and issues discovered during use in the field
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:
- Bachelor of science or engineering degree in biomedical, mechanical, system or applied physics
- Minimum 3 years of quality engineering experience in a multi-disciplinary environment in a regulated industry, preferably in the area of high-risk medical devices
- Ability to learn quickly and understand complex products and processes
- Proven experience with taking the lead with troubleshooting techniques, problem-solving, and root cause analysis
- Proven written and verbal communication and technical documentation skills
- Well-developed interpersonal skills with the ability to interface effectively across multiple functions and at various levels of the organization
- Demonstrated leadership skills and ability to drive results in a timely manner
- Experience working in environments compliant with ISO 13485 and US FDA Quality System Regulation is desired
- The willingness and ability 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!
How to apply
To apply for this position, please send a cover letter and resume to email@example.com using “410 Quality Engineer – Clinical” as the subject line. Indicate in your cover letter why you are interested in Kardium and in this specific position.
Thanks in advance for your interest in Kardium!
Kardium is a technology pioneer developing devices to address cardiovascular diseases. The company was founded in 2007 by a team with a track record of excellence in medicine, business, and engineering. Focused on building a world-class, internationally dominant medical device company, we believe in having lots of fun while working hard. We hire top individuals who are strong team players and trust them to make the right decisions to achieve our goals. Kardium has repeatedly been selected as one of the “Best Companies to Work for in BC” by BC Business Magazine and has ranked as the #1 Life Sciences and Health Services Company. In 2015, and again in 2021, Kardium was also awarded “Medical Technology Company of the Year” by Life Sciences BC. Visit our website at kardium.com.
To apply for this job email your details to firstname.lastname@example.org.