By joining the Kardium team, you can help make a difference in the lives of millions around the world. Kardium is developing a ground-breaking medical device for the minimally invasive diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications.
In this critical role, you have the direct responsibility for Kardium’s quality control activities to support our product release. Specifically, you will push forward our quality program to significantly improve efficiencies and ensure compliance to all regulatory requirements. You will work collaboratively with the engineering and manufacturing teams to analyze new developments to determine the appropriate balance of quality and efficiency. The quality team’s daily activities are overseen by the Quality Control Planner, allowing you the opportunity to investigate and evaluate complex problems and apply your in-depth knowledge to create effective solutions.
What you’ll do
As the Quality Control Manager, your responsibilities include:
- Leading the development of quality control procedures within the manufacturing process, with a focus on mechanical subsystems
- Ensuring that adequate IM&TE is specified for the metrology needs of the company’s medical device projects and that the company’s metrology laboratory and IM&TE continues to be suitable
- Working collaboratively with the Quality Control Planner to coordinate quality control activities, such as incoming and in-process inspections
- Coordinating quality control support for various research and development activities, as well as, reviewing and approving quality control inspection specifications
- Supporting root cause investigations and resolution of quality problems
- Undertaking hands-on quality control tasks to add bandwidth to the Quality Control Team as needed
- Overseeing the team’s performance management activities, such as training activities and team development
What you bring to the team
Our Kardium team is smart, creative, and passionate about creating cutting-edge medical devices to help improve people’s lives. We work within a collaborative environment based on trust and respect. And we understand that only by working together can we solve the unsolvable. You bring to the team these characteristics, plus:
- A minimum of 5 years’ quality control and mechanical engineering experience in a regulated manufacturing environment where you demonstrated your high attention to detail and rigour and where you gained experience managing the quality control team and operations
- Bachelor’s degree in engineering, preferably mechanical engineering, or other applied science, or equivalent
- Extensive experience with standard measurement tools/systems (calipers, micrometers, height gauges, dial indicators, force gauges, etc.), and with advanced, high-precision CMMs and optical measurement equipment for micro-scale metrology applications, such as complex-featured mechanical parts and subsystems
- Demonstrated excellent knowledge of Geometric Dimensioning & Tolerancing (GD&T) principles and terminology
- An in-depth knowledge of ISO 13485, medical device cGMPs, and regulatory requirements pertaining to quality control
- Excellent leadership and interpersonal skills preferably gained from managing teams and working within a collaborative environment, coupled with an interest in developing people’s careers
- Strong analytical skills and critical thinking honed from investigating and evaluating complex issues
- Well-developed written and verbal communication and technical documentation skills
- The willingness and ability to take on additional responsibilities as appropriate
Why work at Kardium?
We know you are looking for a meaningful career. We can offer you that, and more:
- Every day you know you are making a difference by helping treat a condition that debilitates millions of people worldwide.
- A great working environment with opportunities to develop your skills and knowledge while working with cutting-edge technology.
- An engaged leadership team who believes in mentoring and growing employees’ careers.
- Supportive colleagues and plenty of fun social events to encourage employee interactions.
- And our employees think we are great too – check out Glassdoor to learn more.
How to apply
Apply today by sending your résumé and cover letter to firstname.lastname@example.org, with the job title “152 Quality Control Manager” in the subject line.
Thanks in advance for your interest in working at Kardium!