JOB PURPOSE (ROLE DEFINITION):
The Supplier Quality Engineer
* Will support the Group Supplier Quality Assurance Team Lead with the quality compliance culture within the Group ensuring all staff are aware of the Companies’ Business Management System and the need to adhere to it the requirements;
* Will be responsible for the management of supplier materials, working with suppliers to identify root causes and implementation of effective countermeasures in line with procedures, ISO 13485, Medical Device Single Audit Program (MDSAP) and Medical Device Regulation (MDR);
* Undertake a proactive approach with both internal stakeholders and suppliers to reduce the overall cost of poor quality.
* Responsible for the supplier performance and management program
* Assist with the Management of supplier Non-Conformances (including root cause investigations and CAPA)
* Consult with suppliers on quality issues from failures
* Lead desktop or on-site supplier audits – ISO13485:2016 and ISO9001:2015
* To provide assistance during improvement activities
The position also
* Includes maintaining the Companies Business Management System and ensuring compliance to all applicable regulations and standards;
MAIN DUTIES AND RESPONSIBILITIES
* Ensuring that supplier quality processes needed for the Business Management System within the Group are documented in accordance with Medical Device Single Audit Program (MDSAP), Medical Device Directive (MDD) and Medical Device Regulation (MDR);
* Supporting the promotion of supplier quality awareness of applicable quality requirements and Business Management System requirements throughout the Group;
* Support with the planning, scheduling and conducting internal audits and supplier audits;
* To ensure compliance to all applicable supplier quality standards, regulations and internal procedures by proactively interpreting Quality requirements, and devising and implementing solutions to support the maintenance and enhancement of the Business Management System and quality documentation throughout the Group;
* Manage with input from other business functions, supplier selection, approval and ongoing Supplier evaluation process. Support internal projects by providing guidance on supplier evaluation;
* Managing supplier concessions and SCAR’s;
* Periodic review of supplier certification and documentation;
* To manage, with input from other key stakeholders and work streams, the Supplier Quality performance Score Card analysis;
* To input to Supplier Quality performance for Management Review and other Top Management reviews;
* To participate in the CAPA process;
* Travel to suppliers to perform supplier audits.
MANAGEMENT RESPONSIBILITIES
N/A
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