Quality Engineer
2 weeks ago
Our client based in Sligo are currently recruiting for the position of Quality Engineer as they expand operations.
Responsibilities:
- Provide technical quality support to Project Manager, Design Engineers, Production manager and clients.
- Work closely with Engineering team and the client to establish and maintain compliant product specifications.
- Quality review of process validation plan, protocols, and reports.
- Co-ordinate and contribute to the generation and maintenance of compliant product risk management files.
- Issue, review, and release of lot records to manufacturing.
- Co-ordinate and review of testing and release of sterilise product.
- Quality review of SOP’s, Work instruction’s, template’s, Material specifications etc. to ensure compliance to applicable regulatory standards and cGMP procedures.
- Review and approve product change controls.
- Liaise with suppliers and clients on quality related issues.
- Perform an active role in the maintenance, further development and continuous improvement of the QMS.
- Support QMS as quality coordinator in investigation, root cause analysis, disposition, and corrective action of non-conformances & customer complaints.
- Perform CAPA reports.
- Support clients in product submission to applicable regulatory authorities.
- Conduct internal audits and compilation of associated documentation.
- Support and assist in the preparation for customer and surveillance audits.
- Updates job knowledge by participating in educational opportunities.
Requirements:
- Minimum Degree in a Science or Engineering discipline.
- 3-5 Years’ experience working in a medical device environment.
- Strong knowledge of ISO 13485, FDA regulations 21CFR 820.
- Strong knowledge of MDR & FDA product submission requirement.
- Internal/external auditing experience would be an advantage.
- Validation experience including Sterilization, process and packaging validations would be beneficial.
- Knowledge of Medical Device manufacturing environment including cGMP would be an advantage.
- Strong understanding of the general principles of ISO 14971.
- Strong decision-making ability, coupled with the ability to work on own initiative with minimum supervision and ability to multitask and prioritise is required.
- Demonstrate detailed working knowledge of the medical device industry.
- Excellent written and verbal communication skills, with the ability to communicate appropriately with different Engineering teams, Project Management, suppliers and customers.
- Self-motivated, flexible with a desire to learn new tasks.
For more information and a confidential discussion on the role please contactMichelle Mc Inerney.
michelle.mcinerney@collinsmcnicholas.ie
091 706717
#J-18808-Ljbffr
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