Product Quality Engineer
Maternity Cover 12 Month Fixed Term Contract
£30,000 – £39,000 per annum
About our client
We are currently working with a Global Organisation, who have their UK head office base situated in Kingswinford. Our client is a specialist within their industry and currently they have a requirement for a Product Quality Engineer to join them on a Maternity cover 12-month fixed term contract basis.
Purpose of the role:
To address all product related issues in the manufacturing, assembly, and supplier work streams. To identify opportunities for product and process improvements, ensuring all improvement activities are managed and documented from beginning to end.
Responsibilities of the role:
- Management of the ISIR/PPAP and supplier capability processes for new and modified parts – proactively chasing for samples and resolving issues. Liaising with Central Purchasing with respect to initial supplier audits.
- Identifies, investigates and drives resolution of all product quality related issues.
- Supports PFMEA and DFMEA activities.
- Maintain the company’s Quality Management Systems ISO9001, ISO 13485 and FDA QSR requirements.
- Support implementation of ISO 13485.
- Internal process and QA auditing (Auditing the process and identifying where potential failure points are and recommending action to address in conjunction with the process owner)
- Cross UK site systems and audit support as required.
- Supporting and taking part in the Engineering change process (ECN and ECR)
- Root cause analysis of field and production failures (including organising or carrying out appropriate measurements and tests required and visiting site to lead and conduct full investigations
- Writing reports and presenting to customers the output of investigations
- Management of the 8D process for non-conforming supplier product
- Supplier visits to resolve supplied product quality problems
- Reporting and inputting into senior management KPI’s and Management review
The Successful Candidate:
- Proven knowledge of auditing experienced in any of: ISO 9001, ISO 45001, ISO 14001 and ISO 13485 and FDA Part 820 Quality System Regulation – ideally lead auditor trained is essential.
- Medical Device quality systems, implementation would be beneficial
- Degree educated in engineering discipline.
- Proven knowledge of SPC/Data analysis knowledge is essential.
- Proven experience with 8D/Problem solving.
- Problem solving to root cause.
- ISIR/PPAP experience
- PFMEA/DFMEA knowledge is essential.
- Excellent communicator, with the ability to work well at all levels
- Analysing and interpreting data with good reporting skills
- Proven prioritising skills with the ability to work well under pressure
What’s on offer?
- 12 Month Fixed term contract – (Maternity Cover)
- Salary: £30,000 – £39,000 per annum