Senior Quality Assurance Engineer – Galway
An excellent opportunity to join a leading medical device organisation in a key role.
- Collaborate with the project teams to facilitate the execution of the design services process and commercialization of new products.
- Provide expertise in the areas of Quality Assurance, Design Controls, etc.
- Development and approval of new product documentation.
- Qualification of new suppliers/ requalification of existing suppliers.
- Ensure that new medical device product development and changes to existing products are conducted in compliance with global regulations.
- Participate in change review process for medical device products.
- Contribute to process improvement efforts by developing and updating procedures and work instructions.
- Develop and maintain documentation in compliance with FDA, ISO, MDD/MDR requirements.
- Process customer complaints and manage customer replies.
- Initiate non-conformance reports & lead root cause analysis investigations.
- Champion continuous improvement through CAPA system.
- Act as the QA representative for Supplier Quality management activities.
- Represent QA as part of the Material Review Board.
- Perform Internal and Supplier Audits.
- Support Notified Body / Regulatory Agency / Customer Audits.
- Collate and trend key performance indicator data.
- Actively participate in management review & compliance meetings.
- BSc. in manufacturing engineering, quality engineering, life science or related.
- 5+ years experience within the Medical Device Industry.
- Proven record of handling multiple tasks simultaneously.
- Proven record of policy and procedure development.
- Must be highly motivated with excellent communication skills.
- Act as a mentor to less experienced colleagues.
- Quality Certification and Lead Auditor Certification advantageous.
- Supplier Quality engineering experience advantageous.
- Sterilization / Microbiology experience advantageous.
- Some travel is a required.
- Must be authorised to work in Ireland.
Please contact Emer Smith to discuss in confidence