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Supply Quality Engineer EMEA

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Regulatory & Quality Assurance
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In this role, you will work within product related quality control across the organisation and with suppliers to ensure continual improvement of processes and products, thus helping reduce defects, problems, etc. You will drive improvements within the organisation and within the supply chain by implementation of relevant and timely actions [including corrective and preventive].

As the Supply Quality Engineer, you ensure new suppliers are chosen based upon assessment for business requirements and to ensure all quality activities and communication with the suppliers are completed including but not limited to validation, product verification, audit and any other required activities deemed needed.

Role Essential Duties and Responsibilities:

Role Specific
• Manage suppliers to reduce number of non-conformances (NC) and to improve quality from the supply chain.
• Provide general support in the development, maintenance and improvement of an International Quality System
• To liaise with internal and external resources in order to drive identification and implementation of related actions [corrective and preventive] in a timely manner.
• Maintain the non-conformance system; ensure content and status of NC record and related actions are maintained as they occur
• Review & trend non-conformance records and prioritise related actions accordingly using a risk based approach
• Conduct non-conformance related investigations and progress related NCR’s to closure
• Work with Hologic to align and address product related quality issues
• Identify new, or changes to existing, supplier quality systems to improve effectively and efficiency
• Conduct quality assessments (Audit) of current suppliers, report findings and recommendations
• Formulate and present supplier quality information as requested. E.g. Manufacturing; Quality; Supplier Business review, SQMT meetings
• Conduct Internal and Departmental audits where required
• Enact first time shipment inspections of instruments and spares
• Participate in Management Reviews and provide data
• Inspection of parts for identification during investigation and effectivity checks
• Investigation of Non-conformances and ability to determine corrective actions suitable for eliminating re-occurrence
• Work cross functionally to ensure activities and potential improvement work is aligned
• Produce weekly and monthly metrics relating to responsibilities, trend and propose corrective actions
• Supplier Selection and evaluation with an Impact assessment to ensure correct suppliers for business
• Build relationships within Hologic and externally with suppliers to clearly promote requirements for Hologic
• Use of quality principles to reach desired output metrics and targets.
• Validation and verification activities to ensure Process capabilities can be achieved
• Flexibility to travel / work to achieve targets as required

General
• Complete Quality System related actions in a timely manner according to procedures e.g. CAPA, NCR [deviation, material faults, internal audit, external audit]
• Adhere to Environmental, Health and Safety policies and procedures. Maintain an appropriate environment for the occupational health of employees
• Use of Quality Tools and principles
• Responsible for maintaining the effectiveness of the Quality system at the site via adherence to applicable policies and procedures
• Identify new, or changes to existing, processes and systems to improve effectivity and efficiency of the Quality system in accordance with the requirements of: ISO 9001; ISO 13485; 21 CFR parts 11 and 820
Qualifications and Experience:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• A qualification in an Engineering / Science subject or relevant experience in an Engineering / Science related function
• Proven knowledge of ISO 13485 / Good Distribution Practices
• Full Clean Driving licence
• Demonstrated capability in leading a team of people in achieving goals
• Demonstrated practical approach towards problem solving
• Good understanding of supplier quality
• Good understanding of HPD (Good Distribution Practices)
• Knowledge of continuous improvement techniques
• Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc. across organisation
• Must be able to work independently and communicate with all levels of the organisation
• Computer literate - knowledge of Word, PowerPoint and Excel an advantage - in order to produce reports, analyse data etc. effectively

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Flexible working hours and travel is required for business requirements

Accountability:
• Co-ordinate Hologic and subcontractor resources to effect product improvements
• To propose ‘QA Hold’ to SC QA Manager or Quality Associate
• To issue and close supplier audit reports
• To authorise use of new suppliers on ASL
• To authorise or hold supplier on ASL / Indirect Suppliers

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