Quality Assurance Engineer, medical device

Location: Mostyn

Quality Assurance Engineer, medical device

Official job title:
Senior Quality Engineer (reporting to QHSE Manager)

Location:

Mostyn
Type:
Permanent

Hours:

Days 8:30-16:00 Monday
- Thurs, 8:00 - 13:30 on a Friday
Salary:
Upto £45,000ic
Additional: 25+ BH holidays, pension (matched 4%, salary sacrifice option), medicash health plan, life assurance scheme, additional holiday purchase scheme.

Russell Taylor is working with an established, multi-sited medical device manufacturer whose portfolio continues to grow; as such they are looking for an experienced quality engineer. This is an ideal role for applicants wanting to move into the medical device sector from highly accredited industries, or for an experienced QE wanting to move over to a company very much on the up!

The Role:

• Supporting to keep existing QMS up to date.

• Will be the key contact for customer and external body complaints and assisting / directing QA and manufacturing staff in their investigations.

• Assisting in driving a culture of quality throughout the business

• Liaising with suppliers on ongoing performance and resolution of supplier quality issues.

• Creating reports on QMS and site quality / environmental performance, for review at senior management and board level.

• Deputising for QHSE Manager at site meetings.

• Working as part of the team producing FMEAs, risk management plans and risk management reports.

• To be an integral part of the internal auditing team for all manufacturing sites and ensuring completion of the audit schedule.

• Working with suppliers to investigate root cause analysis and work with them to achieve permanent corrective actions.

• Assisting QHSE Manager in leading and mentoring quality team.

• Working alongside purchasing and materials management teams in creating supplier performance reporting.

• Liaising with suppliers on requirements and new product introduction.

• Supporting environmental auditing and reporting for the manufacturing sites.

• Supporting continuous improvement teams in the creation of new product production lines and the improvement of existing product production lines.

• Supporting external QMS audits at all manufacturing sites.

• Supporting manufacturing teams in creation of SOPs.

• Supporting in producing company literature (instructions for use etc.).

• Liaising with R&D department in the testing of new products.

The Person :

• The ideal applicant will have worked to ISO 13485/MDR standards, we will look applicants who have worked at other highly accredited industries (aerospace/NADCAP, automotive etc)

• Minimum ISO 9001 auditing experience required (internal)

• Significant experience working in a quality role within a plant based manufacturing environment

• Experience of problem solving (5 whys, 8D etc).

• Creation and use of FMEAs.

• IT literate and able to communicate / report information to senior stakeholders

• Able to interact with wider teams and communicate externally with customers

Important Information:
We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our  on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data.

If you would like further information on the policy or GDPR please get in touch with us