429 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 work closely with the Engineering and Manufacturing teams to ensure that Kardium’s cutting-edge medical devices meet high-quality standards.
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.
- Leads the review of nonconforming material and product, completes root cause analysis and non-conformance investigations, and supports resolution of quality issues
- Reviews and trends product and process quality issues using data analysis and root cause investigation
- Supports production change control activities, including development and maintenance of manufacturing process requirements and control plans
- Responds to quality escalations and provides technical support for troubleshooting and testing
- Develops monitoring plans for manufacturing processes and performs process stability and capability studies
- Leads and/or participates in corrective/preventive action teams and contributes to resolving production, customer, and supplier issues
- Applies and understands statistical methodologies, as appropriate, for conformity assessment and investigative activities to identify potential product and quality system opportunities for improvement
- Collaborates with the Risk Management Team in the conduct and documentation of process risk analyses
- Contributes to the assessment of post-market surveillance feedback, and implement any resulting corrective and preventive actions and necessary improvements to process controls
Experience & Qualifications
- 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
- Demonstrated understanding of engineering change controls, process verification and validation, and production and process controls in a medical device environment
- Ability to learn quickly and understand complex products and processes
- Proven experience with taking the lead with troubleshooting techniques, problem-solving, and root cause analysis
- A sound knowledge of statistics, SPC, FMEA, and process capability is strongly desirable
- 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
- Demonstrated leadership skills and ability to drive results in a timely manner
- Experience working in environments compliant with ISO 13485 and US FDA Quality System Regulation is desired
- The willingness and ability to take on additional responsibilities as appropriate
Skills and Attributes
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 “429 Process Quality Engineer” in the subject line.
To apply for this job email your details to email@example.com.