Job title: Product Quality Engineer
Salary Range: £30,000 to £35,000
A Product Quality Engineer is required with auditing experience and strong problem solving skills. Candidates with experience of the medical industry would be well received.
Due to growth this company, a leading supplier of disability products based in Kingswinford requires a proactive Product Quality Engineer for a new permanent role.
As a Product Quality Engineer you will be responsible for:
- 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 Product Quality Engineer should have the following skills or experience:
- Auditing experience in any of ISO 9001, ISO 45001, ISO 14001 and ISO 13485 and FDA Part 820 Quality System Regulation – ideally lead auditor trained
- Degree educated in engineering discipline
- Knowledge of SPC/data analysis and ISIR/PPAP
- CMM Knowledge and the capability of reading engineering drawings is desirable
- 8D/Problem solving - Problem solving to root cause
- Excellent interpersonal skills at all business levels
- Good presentation and communication skills
- Good at prioritising and managing high workload
- IT Skills (Word/Excel as a minimum)
- ERP knowledge experience (Navision or Microsoft Dynamics AX and CRM)
- Experience of disability equipment or similar industry
Demand for this role will undoubtedly be high and interviews will be arranged very soon. If you want to be considered, please apply today. If you have any questions about the Product Quality Engineer role, please contact Georgia Silk at Jonathan Lee Recruitment.
Your CV will be forwarded to Jonathan Lee Recruitment, a leading engineering and manufacturing recruitment consultancy established in 1978. The services advertised by Jonathan Lee Recruitment are those of an Employment Agency.