Quality Engineer (Supplier) – Medical Devices

Location:
Hampshire

Job Status:
Permanent

Salary/Wages:
£45000 - £45000 /

Reference:
Ref J2676_1585065701

Industry:
  • Engineering

Supplier 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.

Supplier Quality Engineer Responsibilities:

* Co-operating with R&D, Operations and Procurement colleagues to proactively engineer quality and ensure supplier compliance with raw materials, components, and finished products
* Develop and support regulatory compliance gaps at suppliers, including QMS and process development
* Manage alterations to the status of suppliers on the Approved Supplier List, including master file records
* Ensure supplier(s) products are released to Philips according to the agreed specification and quality requirements
* Perform 3rd party product compatibility risk assessments
* Drive quality and compliance development and improvement at suppliers
* Ensure raw material, component specs and drawings are correctly translated to supplier quality requirements, and properly qualify suppliers capabilities
* Ensure that validations are completed, and control plans are in place to ensure quality and compliance
* Ensure correction and prevention activities of suppliers are effective and on time

* Ensure supplier audit schedules are developed and maintained, and that supplier audits are conducted where necessary

Supplier 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

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.

Job Information

Job Reference: J2676_1585065701
Salary:
Salary From: £45000
Salary To: £45000
Job Industries: Engineering
Job Locations: Hampshire
Job Types: Permanent

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