Sector: Life Sciences
Consultant: Connor Filby
Salary: £40000 - £43000
Job Status: Contract / Full Time
SUPPLIER QUALITY ENGINEER
Title: Supplier Quality Assurance (Supplier Quality Professional III)
Reporting Relationship: Reports to Sr. Manager, Supplier Quality Engineering
Travel: Up to 50%
Lead Supplier related quality activity to ensure that suppliers meet the requirements of the QMS relating to purchased products and identify areas for improvement both internally and at suppliers and drive these improvements
Duties & Responsibilities
- Management of Quality requirements of Supplier Quality (SQM), including conducting supplier assessments / audits toward understanding and qualifying supplier’s capabilities, processes and services.
- Creating and managing the audit schedule and follow up and closure of supplier audit findings.
- To work closely with the purchasing team to develop and implement SQM procedures & to ensure that the quality of Raw Materials, Components and purchased finished products are maintained and improved e.g. participation in supplier meetings with purchasing team
- Collaborate with Raw Material suppliers & External manufacturers to ensure maintenance of quality of items supplied including quality agreements where required
- Collaborate with Raw Material suppliers & External manufacturers to ensure management of supplier notified changes at said suppliers with no risk to product quality
- Provide guidance to suppliers regarding requirements of the Medical Device Industry with regard to items supplied
- Works with project teams to define project deliverables, project planning, etc.
- Work closely with purchasing team to ensure continued supply of acceptable materials
- Develops and maintains supplier quality metrics related to supplier rejections, non-conformances, and audit observations etc. Works with corporate quality systems personnel to ensure timely reporting of metrics.
- Manage monthly / semi-annual business reviews on supplier performance and quality assurance
- Assist suppliers in the investigation of Supplier related corrective actions originated by using problem solving tools (process excellence) and effective risk management
- Participate in projects to identify and approve new suppliers for new products, product changes etc. as per procedures.
- Maintain approved supplier list and supplier history records in accordance with quality system requirements.
- Conduct and assist with internal audits of quality departments
- Assist or leads CAPA evaluation and closure as related to the supplier quality processes and or supplier performance.
- Implement, maintain, and improve quality processes as required through internal / external audits or continuous improvement opportunities.
- Assist with notified body audits of KCI to ensure regulatory compliance
Education & Qualifications
- Preferably qualified to degree level or equivalent working experience
- 5 years supplier quality experience
- Experience with MS Office applications including Word, Excel, Access, Project, PowerPoint, & Outlook
- Project Management experience
- Certified to ISO 13485 Lead Auditor Training
- Experience with Medical device manufacturing
- Experience with lean manufacturing and six sigma
- Experience with metrology and inspection techniques
- Experience with FDA 21 CFR Part 803, FDA 21 CFR 11, & FDA 21CFR Part 820
- Experience with Australian Regulatory Guidance
- Experience with JPAL (MO-169)
- Experience with CMDR and MDD
- Experience with ISO 13485, ISO 9001, & ISO 17025