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Job Details

QA\RA Associate - Medical Devices

Company: Clinical Professionals Ltd
Location: Greater Manchester
Reference: J25139
Closing Date: 11 Dec 16
Type: Full Time
Salary (£): On Application
Benefits: £30K Negotiable + Benefits

Job Summary:

QA\RA Associate - Medical Devices Greater Manchester. Our client is the manufacturer of a broad portfolio of Medical Devices which are available globally. They are seeking an ambitious QA/RA Associate with a background working in medical devices

Requirements:

QA\RA Associate - Medical Devices
Greater Manchester

Our client is the manufacturer of a broad portfolio of Medical Devices which are available globally. They are seeking an ambitious QA/RA Associate with a background working in medical devices either in a QA or an RA role to assist the RA/QA Manager in all aspects of quality assurance and regulatory affairs.
This is an excellent opportunity to broaden your experience within a small and successful devices company.

Location:
Cheshire/Greater Manchester - This position would suit someone residing in Manchester, Preston, Rochdale, Blackburn, Liverpool, Wigan, Bolton, Warrington, Stockport, Huddersfield, Halifax, Leeds area or someone looking to relocate.

Salary and benefits:
Negotiable up to £30,000 per annum plus benefits

Job role:
*To be involved in audits conducted by notified bodies and competent authorities as required by the company and in the absence of the RA & QA Manager.
*Ensure that all Quality Agreements with suppliers to the business are fully up to date, signed and agreed by suppliers.
*To ensure that all of the company's product specification are updated in timely manner and comply with the design specifications agreed by the supplier.
*To provide general support to the Quality & Regulatory Affairs Manager, including completing any reasonable ad-hoc tasks requested by management.
*Monitor and track various QMS oriented systems.
*Responsible for maintaining and updating the QMS from time to time as required. Create new documents and update existing documents as per the internal document management system.
*To conduct regular and documented reviews of outstanding actions and gaps which require to be fully addressed.
*Review and update Sterilisation reports from various suppliers
*Where required train and educate the team or company staff on various QA & RA processes and requirements.
*Responsible for the review of current legislation within Europe and on a global basis for changes to legislation affecting Technical File information and submission requirements.
*Compile technical file information as required by the business to be able to comply with the MDD specifically review and update the validation documents from various suppliers.
*Apply the STED format for Technical File compilation and ensure that all materials and information are accurate as required by the requirements of MDD.
*To produce information and data on a monthly basis for management reports relating to Technical File status, updates and gaps as required by the QA and RA Manager.
*To advise the RA & QA Manager of changes in legislation directly affecting the status of Technical Files.
*Management and control of the artwork and packing approval process ensuring that only the latest version of artwork is available.
*Liaison with notified bodies and competent authorities with regard to Technical File details and requirements.

Ideal candidate:
*Experience of working within the medical devices industry (essential)
*Experience of working with contract manufacturers and suppliers
*Experience of ISO 13485 and MDD experience (essential)
*Experience of keeping detailed records
*Experience in dealing with queries and investigation
*Experience with Sterilisation validation ( EtO, Gama)
*Experience in dealing with notified bodies and competent authorities (desirable)
*Experience of Internal Audits (desirable)

Summary:
This is a rare opportunity for a candidate with a baseline of experience within QA/RA related to the medical devices sector to step-up into a specialist role and progress their career.
Job reference:
*J25139

Clinical Professionals is Europe's leading provider of Life Sciences staff with a unique and dedicated medical device team with a deep rooted knowledge of Medical Technology and staffing. Our Medical Devices Team is focused on finding Clinical Research, Regulatory and Quality positions at all levels.

Keywords:
Regulatory affairs, quality assurance, medical devices, MDD, specialist, Cheshire, Manchester, ra, qa, quality assurance, regulatory affairs, mdd, iso 13485, qms, technical file, submissions, 510(k), fda, ce

Apply for this job: QA\RA Associate - Medical Devices

Contact Information:

Address:  Clinical Professionals UK
3rd Floor
33 Blagrave Street
Reading
Berkshire
RG1 1PW
England
Tel:  0044 118 959 4990
Fax:  0044 118 956 0607
Website:  Visit Our Web Site

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