Design Quality Assurance Engineer

To perform this job successfully an individual must be able to capably perform each of the following essential functions: 

Duties:

• Responsible for supporting the Design Control process and ensuring that Design History Files comply with Technopath Clinical Diagnostic (TCD) policies/procedures and applicable 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 in collaboration 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.
• Responsible for maintaining Design Control and R&D procedures to ensure compliance to regulatory or standard requirements.
• 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 in TCD.
• As required perform internal audits to ensure compliance of TCDs quality management system to the requirements of all applicable requirements.
• Perform other related duties as prescribed by the Global Design QA and Risk Manager and Director of Quality Assurance.

Qualifications :

• Educated to a minimum of degree level in Science/Engineering/QA or related discipline or equivalent.
• A minimum of 2 years practical experience required in a quality function or equivalent 
• 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.

Additional Information :

Why Join Us

At LGC Clinical Diagnostics youre not just another employeeyoure a valued team member contributing to a better future. We offer:

• A collaborative supportive environment where your ideas matter.
• Opportunities to work on impactful projects in the healthcare sector.
• A chance to grow professionally while making a tangible difference in peoples lives.

Benefits

• 25 days holidays
• 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

#LGCIJ

Remote Work :

No

Employment Type :

Full-time