Description
My client is a Medical device company in thenorth westofEngland. They are now looking for a Quality Assurance Manager to manage the Quality Assurance function in line with relevant cGMP, FDA QSR 21 CFR 820, ISO13485 and European Medical Device Directive MDD 94/42/EEC as amended, and to be the companies Representative for Quality.- To ensure the QA activities of Products comply with the requirements of Medical Device Directive MDD 94/42/EEC as amended and relevant cGMP, ISO13485 and FDA 21CFR 820.
- Writing, reviewing and approving SOPs (standard operating procedures) to
ensure compliance with relevant Quality Management Systems. - Establish and maintain the Quality Policy and Quality Manual.
- Review, where applicable Quality Technical agreements.
- Writing, reviewing, maintaining and approving specifications ensuring adequate control of all raw materials and bought in goods, work in progress and manufactured products.
- To develop and manage the products audit programmes, including internal, supplier, customer and regulatory bodies to ensure continuing compliance and co-ordination of responses and follow up and close out of non-conformance and corrective and preventative actions.
- Perform supplier and sub-contractor audits on behalf of Products covering a wide range of suppliers and subcontractors in line with the developed audit programme.
- To develop and deliver the company's training programme to all staff for Quality Systems Compliance.
- Attend and participate in various project meeting, including NPD in line with the company's corporate strategy and goals as necessary.
- The management and control of Change Control process and requests.
- To ensure effective monitoring and reporting of key quality performance indicators via the quarterly quality system review.
Essential Requirements;
- Medical Devices sector with a proven experience of operating within a Quality Management Systems with a proven experience in Quality Assurance Management, or Quality Systems Management.
- Fundament knowledge of Medical Device related regulations and compliance
within a Medical Device Directive MDD 94/42/EEC, as amended, ISO13485 and FDA QSR 21 CFR 820 framework. - Experience with Notified Body for Medical Devices - Auditing, Compliance procedures and documentation.
- Writing of Quality Manuals, documentation (SOP and Specifications).
- Internal and External Auditing to ensure compliance.
- Experience liaising with notified bodies and regulatory authorities as required.
This role is paying between £50-60,000 as a starting salary, plus a healthy benefits package. They are looking for someone to start as soon as possible so if you believe you have the correct experience then please send me your CV and I will be in touch shortly.
To find out more about Real please visit www.realstaffing.com