Job Title: Design Quality Assurance Engineer
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Job Overview:
We are seeking a highly skilled and experienced Design Quality Assurance (DQA) Engineer to join our team. As a DQA Engineer, you will be responsible for ensuring that our products meet the highest standards of quality, safety, and compliance with regulatory requirements.
Key Responsibilities:
* Support the Design Control process to ensure that Design History Files comply with applicable policies, procedures, and regulatory requirements.
* Act as the Quality representative on Design Control projects from project initiation through to product launch to ensure compliance to applicable procedures and standards.
* Manage and lead the change control process by liaising with impacted areas to ensure timely and compliant implementation and completion.
* Work collaboratively with R&D, Labelling, Operations, Validation, Business Development, and Supply Chain on design control and change control projects.
* Review and approve all process validation documentation inclusive of plans, protocols, and reports ensuring compliance to applicable procedures and standards.
* Responsible for creation and maintenance of Risk Management Files for each product.
* Facilitate process and design failure mode and effects analysis meetings.
* Perform Post Market Surveillance activities per the requirements of the applicable procedures and regulations.
* Liaise with external customers on change requests.
* Provide training and guidance to staff on the requirements of the design control and change control process.
* As required, perform internal audits to ensure compliance of the quality management system to the requirements of all applicable requirements.
Qualifications:
* Educated to a minimum of degree level in Science/Engineering/QA or related discipline.
* A minimum of 2 years' practical experience required in a quality function.
* Knowledge desirable in relation to risk management; ideally in the IVD or Medical Device industry.
* Thorough knowledge of the applicable regulatory requirements.
* Knowledge of international regulatory requirements relevant to the business.
Benefits:
* 25 days' holiday
* Life assurance & health allowance
* Discounts with local and national retailers
* Free 24/7 Employee Assistance Programme
* Recognition schemes and monetary awards
* Great long-term career opportunities