Process Quality Engineer Jobs

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 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 and Manufacturing teams to ensure that Kardium’s cutting-edge medical devices meet high-quality standards.

What You’ll Be Doing

We seek 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.

Your responsibilities will include:

• Leads the review of nonconforming material and product, completes root cause analysis and non-conformance investigations, and supports resolution of quality issues
• Leads and/or participates in corrective/preventive action teams and contributes to resolving production, customer, and supplier issues
• Develops monitoring plans for manufacturing processes and performs process stability and capability studies
• Collaborates with the Risk Management Team in the conduct and documentation of process risk analyses
• Supports production change control activities, including development and maintenance of manufacturing process requirements and control plans
• Applies and understands statistical methodologies, as appropriate, for conformity assessment and investigative activities to identify potential product and quality system opportunities for improvement
• Contributes to the assessment of post-market surveillance feedback, and implement any resulting corrective and preventive actions and necessary improvements to process controls
• Responds to quality escalations and provides technical support for troubleshooting and testing
• Reviews and trends product and process quality issues using data analysis and root cause investigation

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:

• Demonstrated understanding of engineering change controls, process verification and validation, and production and process controls in a medical device environment
• A Bachelor of science or engineering degree in biomedical, mechanical, system or applied physics; at least 5 years of quality engineering experience in a multi-disciplinary environment in a regulated industry, preferably in the area of high-risk medical devices
• Proven written and verbal communication and technical documentation skills
• Proven experience with taking the lead with troubleshooting techniques, problem-solving, and root cause analysis
• Well-developed interpersonal skills with the ability to interface effectively across multiple functions and at various levels of the organization
• A sound knowledge of statistics, SPC, FMEA, and process capability is strongly desirable
• Demonstrated leadership skills and ability to drive results in a timely manner
• The willingness and ability to take on additional responsibilities as appropriate
• Ability to learn quickly and understand complex products and processes
• Experience working in environments compliant with ISO 13485 and US FDA Quality System Regulation is desired

Why work at Kardium

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

• Supportive and fun colleagues with plenty of social events to encourage people connections
• An engaged leadership team who believes in mentoring and growing employees’ careers
• 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
• Knowing every day that you are making a difference in people’s lives by helping treat a condition that debilitates millions worldwide
• And our employees think we are great too – check out Glassdoor to learn more!

Thanks in advance for your interest in Kardium!