Quality Systems Specialist - Suffolk- £35,000 - £45,000 + Benefits
SRG are currently recruiting for a Quality Systems Specialist to join a rapidly growing Medical Device / Healthcare manufacturing company in Suffolk on a permanent basis at a salary range of £35-45k + Benefits, dependant on experience.
Reporting to the Quality and Site Director, you will be responsible for ensuring that the products placed on the market meet the requirements of the Quality Management System and that regulatory requirements are achieved.
Responsibilities:
* Ensuring compliance with national and international standards and legislation currently ISO13485 and ISO9001.
* Understanding and experience of CAPA and non-conformance.
* Experience of Medical Devices Vigilance Reporting.
* Solid working knowledge of customer complaint investigations and trending activities
* Fully understand and have experience of ISO14971 Medical Devices Risk Management.
* Work closely with Technical and Business Managers to manage manufacturing procedures and systems to achieve and maintain current certification
* Defining quality procedures in conjunction with operating staff.
* Setting up and maintaining controls and documentation procedures.
* Liaising with customers' auditors and ensuring the execution of corrective action and compliance with customers' specifications.
* Writing technical and management system reports.
* Effectively interact with Production and Technical Support teams to maintain product supply and help introduce new products.
* Working with purchasing staff to establish quality requirements from external suppliers.
* Able to write procedures, technical reports.
* Able to review and critique technical reports in order that compliance is maintained.
* Mentoring and coaching both within the Quality Assurance Team and throughout the business to improve the company skillset and understanding of the QMS..
Requirements:
* Experience in quality assurance within the medical devices industry.
* Experience in quality management compliance with ISO 13485 and MDD is a must.
* Actively dealing with CAPA and non-conformances.
* Be able to perform internal/supplier audits and support external audits.
* Good interpersonal skills are essential.
For more information, please call Laith Mustafa on (phone number removed) or email (url removed)
