Senior Supplier Quality Engineer
Location: Galway, Ireland
Are you ready to make a difference in the world of acute care aerosol drug delivery? Our client headquartered in the vibrant city of Galway with offices globally, is seeking a Senior Supplier Quality Engineer to join our award-winning team. Recognized through multiple MedTech awards and an eight-time winner of the Zenith award for Respiratory Care Excellence in North America, they are at the forefront of innovation in patient care.
Key Responsibilities:
- Supplier Quality Management: Ensure suppliers deliver high-quality parts, materials, and services. Build and maintain strong relationships with suppliers through effective collaboration, communication, and monitoring/planning activities.
- Team Leadership: Train, develop, and manage resources within the Supplier Quality Team. Ensure objectives are communicated and met within agreed requirements.
- Quality Objectives: Support Quality Management in developing key objectives and strategies for continuous growth of personnel and quality system improvements.
- Process Validation: Manage and lead all process validation activities (IQ, OQ, PQ) with existing and new suppliers.
- Quality Documentation: Ensure timely and effective closure of Quality System documentation (Audit Actions, SCARs, SCNs, PANs, etc.).
- Project Support: Provide Quality Engineering support for project activities including Design Improvements, Supplier Transfers, Cost Improvements, and New Product Introductions.
- Inspection Plans: Work with Manufacturing Quality to establish inspection plans, frequencies, and test methods for incoming materials/parts.
- Continuous Improvement: Champion continuous process improvement. Analyze feedback and implement appropriate problem-solving and statistical techniques to enhance product quality and process efficiency.
- GMP Compliance: Ensure compliance with GMP standards within Project Teams and Supplier Engagement.
Qualifications & Experience:
- Education: BE/BS Degree. A Post-graduate qualification in Quality Assurance is preferable.
- Experience: At least eight years of Quality Engineering experience within the medical device or pharmaceutical industry.
- Standards Knowledge: Understanding of ISO 13485 and FDA QSR standards.
- Validation Expertise: Experience with reviewing and approving process validation activities (IQ, OQ, PQ, TMV).
General Requirements:
- Ability to work independently and within project teams.
- Strong team member with the ability to drive innovative quality improvements.
- Excellent communication skills to effectively interact at all company levels and with suppliers.
- Strong organizational skills with high attention to detail.
- Commitment to promoting high levels of professional quality engineering.
If interested in learning more about this fantastic opportunity, please forward your CV using the apply button. For more information, please contact [email protected]
