About Your New Employer:
Medical device engineering company offering a range of development and manufacturing services from initial design assessment, through to the provision of sterile finished product for the European and US medical device market. This employer provides a dynamic and inclusive environment for Employees.
About Your New Job as a Quality Engineer
* Work closely with the 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 sterilized product.
* Quality review of SOPs, Work instructions, templates, Material specifications etc. to ensure compliance with 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.
* Other duties as may be assigned from time to time by their manager.
What Skills You Need to Succeed as a Quality Engineer:
* 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 requirements.
* Internal/external auditing experience would be an advantage.
* Validation experience including Sterilization, process, and packaging validations would be beneficial.
* Knowledge of the 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 the ability to multitask and prioritize is required.
* Excellent written and verbal communication skills, with the ability to communicate appropriately with different Engineering teams, Project Management, suppliers, and customers.
* Excellent attention to detail with strong numerical and problem-solving ability, while maintaining awareness of longer-term objectives.
What’s on Offer for Candidates for a Quality Engineer:
* Salary of 40k – 52.5k DOE
* Benefits package: health insurance, pension, educational assistance, flexible working policy
* Fantastic career development opportunities
What’s Next
* Apply now by clicking the “Apply Now
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