352 Process Quality Engineer
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.
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 production and post-production phases:
- Participating in the review of nonconforming product and materials as required, including writing detailed root cause analysis and non-conformance investigations.
- Supporting production change control activities, including maintenance of Control Plans
- 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
Additionally, in the design transfer phase, you will collaborate with Engineering and Manufacturing to ensure products are effectively and appropriately transferred to production. Specifically:
- 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
- Supporting the development and implementation of Control Plans
- Collaborating with the Risk Management Team in the conduct and documentation of process risk analyses
Experience & Qualifications
- A bachelor of science degree (biomedical, engineering, 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
- Proven experience with troubleshooting techniques, root cause analysis, non-conformances, CAPAs and quality tools generally used by a Quality Engineer
- A sound knowledge of statistics, SPC, FMEA, and process capability
- Experience working in environments compliant with ISO 13485 and US FDA Quality System Regulation is preferable
- 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.
Skills & Attributes
- Proven problem-solving skills and ability to drive continuous improvement, including structured and methodical thinking
- Demonstrated leadership skills and ability to drive results
- Ability to listen and gather feedback from employees, present recommendations and ideas and build consensus
- High level of technical acumen and ability to understand technical documents and drawings
- Proficiency with MS Office software, in particular the use of Excel
- Flexible and able to take on additional responsibilities as required
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 “352 Process Quality Engineer” in the subject line.
To apply for this job email your details to firstname.lastname@example.org.