245 Quality Engineer, 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 ensuring consistent quality is produced for pre-clinical and early clinical testing and for commercial devices, you will focus on manufacturing and operations support.
In the design transfer phase, you will collaborate with Engineering and Manufacturing to ensure products are effectively and appropriately transferred to production. Specifically:
- Supporting the development and implementation of Control Plans
- Collaborating with the Risk Management Team in the conduct and documentation of process risk analyses
- Implementation of process capability and stability assessment and monitoring systems
- Assisting the Quality Control and Engineering teams in the development and optimization of incoming and in-process quality control procedures
In the production and post-production phases:
- Supporting production change control activities, including maintenance of Control Plans
- Participating in the review of nonconforming product and materials as required
- Monitoring and evaluating product quality, and process stability and capability
- Identifying trends, and provide solutions for corrections or improvements
- Working collaboratively with Manufacturing to solve in-house quality issues by participating in the conduct of nonconformity investigations and root-cause analysis, and recommending corrective action to prevent recurrence
- Contributing to the assessment of post-market surveillance feedback, and implement any resulting corrective and preventive actions and necessary improvements to process controls
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, applied physics, etc.) or equivalent engineering degree
- At least 3 years of quality engineering experience in a multi-disciplinary environment in a regulated industry, preferably in the area of high-risk medical devices
- An in-depth knowledge of metrology as well as quality planning, execution, coordination, and documentation
- A sound 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 email@example.com, with the job title “245 Quality Engineer” in the subject line. And if you are a recent grad please include your GPA in your resume.
To apply for this job email your details to firstname.lastname@example.org