Product Quality Engineer – North Hampshire – Medical Devices
Our client is a rapidly growing medical devices company in North Hampshire that develops innovative electronics medical devices for a range of critical-care applications. I am looking for an experienced Supplier Quality Engineer, ideally with exposure in Medical Devices that is looking to join a progressive, forward thinking company.
Product Quality Engineer Responsibilities:
* Ensuring that appropriate quality plans include all stages of the product life cycle
* Validate key design inputs like: usability, reliability, performance & manufacturability
* Provide oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product lifecycle
* Perform analysis on product quality performance and post-market product quality
* Leading quality related problem solving and root cause analysis during both design and manufacturing
* Act as a point of contact responsible to ensure that software and hardware design meets quality and compliance standards for every part of the product lifecycle
* Quality Monitoring for the entire QMS, and the elements applicable through the product lifecycle
* Work effectively with all levels of management to ensure plans can be supported and that costs/resources needed to implement the plan are available.
Product Quality Engineer Profile:
* Bachelor’s degree in engineering or equivalent technical experience
* Demonstrable experience in Quality Engineering and CAPA processes in a medical device or highly regulated industry
* Working knowledge of medical device regulations (21CFR), MDD/MDR, other regulations and standards including ISO14971 & IEC 60601
* Prior knowledge of the new product design and development process in a regulated environment; ideally medical devices
* Able to understand and analyse complex problems, which may including software and hardware design issues
* Strong Project Management skills, including ability to project manage all activities, ability to prioritize and time manage effectively
* Excellent written and verbal communication skills
* Must be able to travel locally and internationally / full driver’s license
* Lead auditor training to ISO13485:2016 (beneficial)
* Able to read, understand/ interpret Engineering drawings
* Able to read, understand/ interpret Engineering drawings and ability to use basic measurement hand tools, e.g. vernier gauges, height gauges, torque drivers
This is an excellent role within a market-leading business, and as such my client offers a highly competitive package with great benefits.
If you’re interested in this position, then don’t hesitate to get in touch with Jamie @ TEC Partners directly.