Company Profile & Job:
Dawnlough is a progressive precision engineering company providing expertise in design and manufacture of specialist parts and equipment for the aerospace and medical device industries. It has recently joined the Acrotec Group, an independent group of professional specialised in micro-mechanics precision. Dawnlough serve various industries and are primarily involved in MedTech and Aerospace.
Dawnlough is looking for individuals who are skilful, positive, and collaborative, with a strong willingness to learn and a desire to develop their skills in a dynamic environment. This is a brilliant opportunity for an individual who is looking to join a successful business where they can use and develop their skills to their full potential.
Your Role:
We are seeking a dynamic Validation Engineer with robust project management skills to join our team. This role requires a strong background in medical device manufacturing, including expertise in validation processes and regulatory compliance. The successful candidate will also manage projects from customer interaction to product delivery, ensuring seamless execution and exceptional quality
Key Responsibilities:
- Lead project management initiatives from customer communication through to product production, ensuring all quality standards are met.
- Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Develop PFMEA and Control plans as parts to meet validation or PPAP requirements
- Ensure compliance with ISO 13485 standards and support audits and inspections.
- Collaborate with cross-functional teams to implement quality improvements and corrective actions.
- Analyze quality data and trends to enhance product reliability and performance.
- Assist in FDA submissions and maintain up-to-date knowledge of regulatory changes.
Qualifications:
- Bachelor’s degree in Engineering, Quality Assurance, or a related field.
- Minimum of 3 years of experience in quality engineering within the medical device industry.
- Proven project management experience, from customer interaction to product manufacturing.
- Proficiency in IQ, OQ, and PQ validation processes.
- Strong knowledge of ISO 13485 and FDA regulations.
- Excellent analytical, problem-solving, and communication skills.
- Must be freely be able to work in Ireland or have current work permit
Why Join Us?
- Be a part of a forward-thinking company that values innovation and excellence.
- Enjoy opportunities for professional growth and development.
- Work in a supportive team environment with a focus on quality and customer satisfaction
If you are proactive with a passion for engineering precision and a knack for problem-solving, we would love to hear from you!
How to Apply:
Submit your resume and cover letter to [email protected] with the subject line "Quality Engineer - [Your Name]."
Join us in making a difference in healthcare & aerospace through quality engineering and project management excellence!
Job Types:
· Full-time, Permanent
· Location: On-Site, Galway
Benefits:
· Company Health Insurance
· Bike to work scheme
· Company events / Sports and Social Club
Job Type: Full-time
Benefits:
- Bike to work scheme
- On-site parking
- Private medical insurance
Work Location: In person
Reference ID: Validation Engineer
