Quality Engineer

About the Company

In this fast paced, dynamic environment you will provide Quality Engineering support to the R&D and Manufacturing teams. Ideally you will bring some previous experience in a Medical Devices environment but this is not a requirement. A Degree in Mechanical or Biomechanical Engineering or similar is a requirement.

On offer is a permanent position with an attractive benefits package and progression opportunities at this expanding client.

About the Position

Key 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.

Experience/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.

Remuneration Package

CONTACT

For more information on the role or any other Engineering or Life Sciences roles call Nigel on 087 3618142 or email me or click the apply button below.
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