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Job Details

Supplier Quality Engineer

Company: ProClinical Ltd
Location: Montpellier
Reference: QA.WH.15388
Closing Date: 26 Feb 18
Type: Contract
Salary (£): Negotiable

Job Summary:

ProClinical are currently recruiting for a Supplier Quality Engineer job in Montpellier. The company is a multinational medical device manufacturer and are at the forefront of biomaterials, musculoskeletal, instruments and other orthopaedic technologies. ...


ProClinical are currently recruiting for a Supplier Quality Engineer job in Montpellier. The company is a multinational medical device manufacturer and are at the forefront of biomaterials, musculoskeletal, instruments and other orthopaedic technologies. The Supplier Quality Engineer (SQE) is responsible for delivering all aspects of the Supplier Operations Quality Assurance function on an on-going basis, in line with the Clients Quality Management System and Quality Policy, to ensure that our Clients products and services are fit for purpose and meet customer expectations. The SQE is responsible for ensuring that suppliers continue to develop and implement best practices that emphasise defect prevention, reduction in variation and waste, to provide for continuous improvements and continue to meet quality standards required to minimise quality costs and maximise customer satisfaction, whilst ensuring that procedures and processes are adhered to.

Job Responsibilities:

* Ensure Supplier’s compliance and assist with adherence to the Quality Management System identified by ISO9001/13485.
* Carry out on-site Supplier Audits to ensure that their ISO 9001/13485 Quality Management System is adhered to.
* Lead the supplier approval process by assessing manufacturing/technology capabilities and risks.
* Work with Engineering (R&D and Manufacturing Engineers) to define process parameters and criteria to ensure supplier process capability is effective to meet product and process requirements.
* Analyse supplier capabilities. Develop and maintain supplier quality metrics specific to Clients products.
* Perform root cause analysis and resolve problems of supplier quality issues via the Non-Conformance Report (NCR) procedure.
* Track supplier issues using the Supplier Corrective Action Report (SCAR) system.
* Perform on-site supplier visits for root cause analysis and verification of correction actions of supplier quality issues
* Facilitate the escalation of quality issues within assigned projects to the relevant suppliers.
* Work with the supplier directly and create correction action plans to address process or product failures.
* Support R&D functions in the presenting of new products/ideas to suppliers.
* Support new product launches to ensure that supplier quality meets the required standards.
* Support and lead process improvement activities at the supplier.
* Communication of new drawings, specifications and revisions to the relevant supplier.
* Review supplier manufacturing processes, collaborate with suppliers on process improvement and value enhancement opportunities.
* Report on Key Performance Indicators (KPI) and adherence to process, to prevent occurrence of any non-conformity relating to product, process or system.
* Support the Operations Quality Manager to monitor and report on supplier product quality and performance.
* Identify the requirement for, and, perform regular supplier Quality Systems audits and provide support for identified improvements.
* Undertake any other specific tasks as detailed by the Operations Quality Manager
* Ensure own compliance with health and safety regulations

Skills and Requirements:

* Degree qualified with a degree in either Engineering or Science or equivalent experience gained in industry
* Any professional qualification relating to Supplier Assurance
* Experience and competencies required
* Experience within manufacturing & product development environments with experience within the Medical Device industry.
* Experience of developing, monitoring and maintaining Supplier Assurance Systems. Good knowledge of ISO13485.
* Experience of leading significant Supplier Assurance Systems improvements.
* Able to work seamlessly with internal and external teams.
* Demonstrates a positive attitude to change and contributes to new ideas and improved ways of working.
* Experience of conducting audits.
* Excellent organisational skills with a particular attention to detail. Excellent written and verbal communication skills.
* Good knowledge of the European Medical Devices Directive or MDD.
* Good knowledge of FDA 21 CFR’s (in particular part 820)
* Good knowledge of d ocumentation requirements for Medical Device regulations.
* Capable of identifying and estimating risk.
* Good knowledge of the European In Vitro Diagnostics (IVD) Directive
* Good knowledge of maintaining metrics or KPI’s.
* Fluent French and English (writing and speaking)

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Will Hitchcock on +44 203 0789 554 or upload your CV on our website -
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Apply for this job: Supplier Quality Engineer

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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