Senior Supplier Quality Engineer

HERO Recruitment are delighted to share we are working in partnership with an innovative and global leader in Medical Technology to attract a Senior Supplier Quality Engineer in Galway. This is a permanent position reporting to the Supplier QA Manager.

The Senior Supplier Quality Engineer is responsible for leading quality engineering activities within supplier controls and project teams in addition to the monitoring, approval and qualification of existing and new suppliers whilst managing all process validations.

Key Responsibilities:

• Ensuring that suppliers deliver quality parts, materials, and services.
• Build Strong relationships with suppliers focusing on strong collaboration, communications, and monitoring/planning activities.
• Appropriately train, develop and manage resources within Supplier Quality Team to ensure objectives are communicated and delivered within agreed requirements.
• Supporting Quality Management in the development of key objectives and strategies to ensure continuous growth of personnel and quality systems improvements.
• Manage and led all process validation activities including IQ, OQ and PQ with existing and new Suppliers.
• Ensure effective and timely closure of Quality System documentation (Audit Actions, SCAR’s, SCN’s, PAN’s, etc.).
• Lead Quality Engineering support on project activities i.e.: Design Improvements, Supplier Transfer’s, Cost Improvements, and New Product Introductions etc.
• Work with Manufacturing Quality to establish inspection plans, frequencies, and test methods for incoming material/parts.
• Champion continuous process improvement and, in conjunction with other functions, analyze feedback and identify and implement appropriate problem solving and statistical techniques to improve quality of manufactured product and overall effectiveness and efficiency of processes.
• Overall responsibility for GMP standards and compliance within Project Teams and Supplier Engagement.

Qualifications & Experience:

• BE/BS Degree. 
• A Post-graduate qualification in Quality Assurance is preferable although not mandatory.
• At least 6 years Quality Engineering experience or related role within the medical device/pharmaceutical industry.
• Understanding of ISO 13485 and FDA QSR standards.
• Experience with reviewing and approving process validation activities (IQ, OQ, PQ, TMV etc)

For further information on this role in please contact Mark Wilson on 0860449473 or email talent@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.