246 Quality Engineering Manager, Medical Devices
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 non-invasive diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications.
In this role, you will help define and implement our quality planning standards to support design, development, and production of Kardium’s products. As the subject matter expert, you will work closely with the Engineering and Manufacturing teams to plan the key aspects of quality assurance and would be heavily involved in the quality engineering of cutting-edge medical devices.
What you’ll be doing…
Your role spans over several stages of Kardium’s products life cycle. For devices in the early stage of development, you will focus on the planning for, and ensuring, consistent quality is produced for pre-clinical and early clinical testing and for commercial devices, you will focus on manufacturing and operations support. You will apply your ISO 13485 and US FDA QSR expertise and quality engineering knowledge to assist the Quality Assurance, Engineering, and Manufacturing teams in the identification and resolution of quality issues.
As the Quality Engineering Manager, your responsibilities include:
- Leading investigations of in-house and supplier quality issues and recommending corrective actions to prevent recurrence
- Leading investigation and disposition of product non-conformities, trend analysis of quality issues, and taking initiatives to improve quality of product
- Assessing post-market surveillance feedback, and implementing any resulting corrective and preventive actions and necessary improvements to process controls
- Planning and implementation of process capability and stability assessment and monitoring systems
- Supporting the development, implementation, and maintenance of Control Plans
- Monitoring and evaluating product quality, identifying trends, and providing solutions for corrections or improvements
- Collaborating with the Risk Management Team in the conduct and documentation of process risk analyses
- Identifying Quality Engineering Team human resource needs and ensuring the team is adequately staffed
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 bachelor of science degree (mechanical, biomedical, applied physics, etc.) or equivalent engineering degree
- 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
- In-depth knowledge of quality planning, execution, coordination, and documentation
- In-depth knowledge of statistics, SPC, FMEA, and process capability
- Experience working in environments compliant with ISO 13485 and US FDA Quality System Regulation
- 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
- 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 in the people’s lives by helping treat a condition that debilitates millions worldwide
- A great working environment with opportunities to develop your skills and knowledge
- 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…
If this position appeals to you, apply today by sending your résumé and cover letter to firstname.lastname@example.org, with the job title “246 Quality Engineering Manager” in the subject line.
To apply for this job email your details to email@example.com