Senior Medical Devices Quality Engineer required by frowing multinational in Galway
- Maintain company compliance with FDA Quality System Regulations and ISO 13485 standards.
- Actively participates in internal audits.
- Provide customer related quality and regulatory inquiries support.
- Compiles and writes training material and conducts training sessions on quality control activities.
- Provide QE direction, analysis and recommendations for Product Development to successfully launch new products.
- Lead implementation of continuous improvement projects.
- Lead and provide Project Management support as needed.
- Develops standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields.
- Devises sampling procedures and designs and develops forms and instructions.
- Performs measurement system analyses to evaluate test and inspection equipment.
- Leads disposition of discrepant material and devises process to assess product quality and reliability.
- Monitors and directs engineering group on calibration requirements.
- Lead supplier approval and qualification of new/revised items.
- Direct support for FDA and ISO inspections and registration.
- 8 years experience in the Medical Device or other regulated industry, such as QSR and ISO 13485.
- Experience with FDA and ISO 13485 Certification inspections.
- 3+ years Project Management experience, supervising diverse teams.
- Must be adept in use of computer software for the analysis of data, Microsoft Excel and Minitab.
- Quality Engineering certification (CQE) preferred or equivalent body of knowledge.
- Experience with Lean Manufacturing and Six Sigma is a plus.
- Up to 20% travel may be required.
If you are ready to explore the next chapter in your career and would like to join an established multinational where you can grow your experience, please forward your cv to Emer Smith and we can arrange a call to discuss this role in confidence.