Quality and Regulatory Affairs Manager

Quality Assurance Manager

K2 Medical Systems was established in 1999 and develops software and hardware medical devices to help improve maternity care for both mothers and their babies and for hospitals. K2MS is an innovative and leading edge company using latest technologies and have enjoyed considerable success worldwide.

Our Quality Manager is a key role within the company reporting directly to the Director with an opportunity to have a real impact on the company’s future development and culture. The organisation is undergoing significant market expansion so it is a great time to join and be part of the success of this company. We have a mature Quality System and successfully completed our transition audit to ISO13485:2016 in February 2018 & ISO9001:2015 in September 2017.

Key Responsibilities

Organises, plans, directs, and controls all Quality Management functions including product registration, complaint handling and reporting, critical process management e.g. CAPA, internal and external auditing of the quality systems and supporting R&D.

Develops policies and procedures to ensure efficient and effective operation of the Company quality system and regulatory requirements.

Ensuring that the conformity of all products and devices are appropriately checked in accordance with company’s QMS before being released.

Maintaining technical files and declarations of conformity for company’s medical devices.

Ensuring Post Market Surveillance obligations are communicated and fulfilled throughout the company

Skills Required

· Significant experience in Quality Assurance

· Proven background in leading teams and driving quality initiatives throughout an organisation

· Strong line management experience

· Proven ability to work in a cross functioning medical device manufacturing environment

· A working knowledge of Information Security, ISO 27001, NHS IG Toolkits would be an advantage

Salary

Commensurate with the seniority of the position and dependent on experience.

Closing date for applications: 29th November 2018

Please send a CV with a full description of experience and letter of application.