About Your New Employer
As an outsource partner to several of the world's premier medical device businesses, my client in Spiddal designs, develops, and manufactures implanted medical devices.
Their focus on cutting-edge technology and biomaterials knowledge fosters a vibrant culture that produces next-generation implantable solutions.
About Your New Job
- The position requires a proven candidate with a background in leading high-value manufacturing engineering support within a GMP-regulated medical devices industry.
- Candidates must have a minimum of 5 years of experience in leading processes, continuous improvement, and compliance support within an ISO-8 (or higher) clean environment.
- The successful candidate will liaise heavily with cross-functional NPI (new product introduction) teams which can encompass R&D, manufacturing, engineering, maintenance, EH&S, quality-engineering, and supply-chain functions. He/she will hold a leadership role in maintaining high quality/ performance/ safety standards on all assigned implant-products platforms.
What Skills You Need
- A Bachelor’s degree in manufacturing engineering, biomedical engineering, quality engineering, or a related field and 5 years minimum experience is required.
- People and Project management experience are essential.
- Strong familiarity with FDA GMP/QSR; ISO 13485 and medical standards is essential.
- Experience in transferring products from design into commercial manufacturing is highly desirable.
- Solid knowledge of PFMEA development, and IQ/OQ/PQ validation is essential.
- Candidate must be highly motivated and passionate about meeting production, targets with excellent time-management, presentation, communication skills, technical writing skills, and organizational skills with the ability to work independently or as the leader of a team.
- Possess strong leadership and analytical skills, with a hands-on approach
What’s on Offer
- Competitive salary
- Career progression
Apply now by clicking the “Apply Now" button or call me, Emma Ryan on (086) 440 5143 Or if the job isn’t quite right but you are looking for something similar, please get in touch
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