About the Role
Quality Engineer needed to provide technical quality support to R&D, Manufacturing teams, Design Engineers and clients. Medical Devices experience required.
Key Responsibilities
* Provide quality support to Project Manager, Design Engineers, Production manager and clients.
* Work closely with Engineering team and client to establish compliant product specifications.
* Review process validation plans, protocols and reports.
* Coordinate generation and maintenance of compliant product risk management files.
* Issue, review and release of lot records to manufacturing.
* Coordinate testing and release of sterilized product.
* Review SOPs, Work instructions, templates, Material specifications for regulatory compliance.
* Approve product change controls.
* Liaise with suppliers and clients on quality issues.
* Maintain QMS, investigate non-conformances and customer complaints.
* Perform CAPA reports.
* Support product submission to regulatory authorities.
* Conduct internal audits and compile documentation.
* Prepare for customer and surveillance audits.
Requirements
* Bachelor's Degree in Science or Engineering discipline.
* 3-5 years medical device experience.
* Knowledge of ISO 13485, FDA regulations and MDR requirements.
* Internal/external auditing experience beneficial.
* Validation experience, including Sterilization and packaging validations.
* Strong numerical and problem-solving ability.
* Excellent written and verbal communication skills.
* Ability to multitask and prioritize tasks.
Remuneration Package: Competitive salary and benefits package available.