|Location: Crawley, West Sussex||Salary: £35000 - £40000 per annum|
|Sector: Medical Devices||Type: Permanent|
|Contact: Matt Henocq||Job Published: 27 days ago|
The purpose of the role of SQA Engineer is to offer quality engineering support in order to optimize supplier quality in my clients supply chain. Work with suppliers to assure and improve the quality of products and services supplied to my client and its customers.
The role involves all stages of the product lifecycle, using customer, factory and supplier feedback to improve supplier quality.
- Management of supplied material quality issues raised by the factory. Working with factory and suppliers to ensure problems are effectively resolved and investigations are fully documented. Effectively contain issues to minimise repeat issues affecting the factory. Instigate and implement effective corrective and preventative actions (CAPA). Where appropriate, develop quality plans with the suppliers and Engineering.
- Continually aim to establish and implement activities which support the movement to a supplier quality regime which reduces the need for upstream inspection and testing activities.
- Plan, conduct and fully document first article inspections on new and updated parts to ensure compliance to the drawing specification.
- Working with suppliers, plan, conduct and document appropriate activities to assure the continued quality of critical parts. Typically achieved by auditing supplier inspection results, reviewing part, manufacturing, test and inspection processes at suppliers premises.
- Conduct approval and surveillance audits in line with the requirements of ISO9001 or ISO13485 and the Quality Agreement in place with the supplier.
- BSc. or MSc. Degree (science, eng, business) or equivalent work experience.
- A strong electro and/or mechanical engineering and manufacturing background is essential.
- ISO9001 or preferably ISO13485 Lead Auditor qualified or equivalent auditing experience.
- Excellent written communication skills - including report writing, CAPA investigations and quality plans.
- Excellent verbal communication skills - communicating technical and CAPA investigation with suppliers, co-workers and senior management. Able and willing to present when required.
- Strong interpersonal communication and positive influencing skills, capable of working on own initiative whilst also being an effective team player.
- Impartial and objective decision maker.
- Able to read technical drawings and undertake part inspections using a variety of basic measuring equipment (e.g. digital Vernier's, micrometers and shadow graphs)
- Demonstrable experience of working with external suppliers. Experience with global suppliers preferable.
- Full Driving License.