Design Quality Assurance Engineer
Design Quality Assurance Engineer
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Job Description
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.
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.
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 longterm career opportunities
#LGCIJ
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
