Quality Engineer – Medical Devices
£40.00- £45.00 Per Hour
The Quality Engineer works with local R&D product development teams and operations personnel to ensure compliance to the Quality System from product concept through industrialization and post market support. This position assists in the development and implementation of GMP policies and procedures for management of drug injection system design control processes. Additional responsibilities will include the evaluation of the precision, accuracy, and conformance to specifications of products, components, and/or equipment. Conduct external audits as needed.
- Actively participate in the development of the Runcorn site Quality System (QS) in support of design control development of medical devices
- Provide QA support for the evaluation laboratory, development workshop and design and development teams as required.
- Execution and follow up of internal and external CMO audits. Travel as required.
- Assist in selection and qualification of device CMOs.
- Negotiate quality agreements with CMO’s as needed.
- Participate in IQ/OQ/PQ activities including the drafting or review of protocols and validation reports.
- Actively participate in the compilation, review and auditing of Design History Files – both internal and external to the Business
- Compile training material and conducting training sessions on quality protocols internally/externally
- Liaise as needed with business sites to assure compliance with combination product regulations.
- Gap analysis activities both internal and external.
- Assists in tabulation and evaluation of data concerning quality and reliability
- Participates in Corrective Action / Preventive Action (CAPA) initiatives
- Oversee Continuous Improvement activities in the device suppliers.
Education and Experience:
- HND Level
- Experience in the medical device, pharma, and/or combination products field
- Working experience in the medical devices, combination products or other FDA regulated (GMP) industry
- Working experience of GMP Quality Systems and related requirements.
- Previous experience on design development teams is highly desirable
- Audit management experience with both CMO’s and internal customers
- FMEA / risk analysis experience highly desirable
- Medical device/combination product industrial experience
- Injection moulding experience highly desirable
- Working knowledge of Device regulations (FDA 21 CFR820, ISO 13485, ISO 14971 and other ISO standards relating to drug injection systems, EU Medical Device Directive, ASTM, ANSI)
- Working knowledge of medical device regulatory requirements (US, Canada and Europe) highly desirable
Please send your CV and call Alex Quegan at gap technical on 01925 406 525
If you have any questions or are interested in any other opportunities we may have, please do not hesitate to contact on 01925 406 525
This vacancy is being advertised on behalf of gap technical who are operating as an employment business.
gap technical are committed to the selection, recruitment and development of the best people, basing judgements solely on suitability or the job.
£40 - £45 per hour
Job Start Date:
Days Only (Mon-Fri)