Quality and Regulatory Affairs Manager

Location
Plymouth, Devon
Salary
Commensurate with the seniority of the position and dependent on experience.
Posted
01 Nov 2018
Closes
29 Nov 2018
Sectors
Management
Contract Type
Permanent
Hours
Full Time

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.

Apply for Quality and Regulatory Affairs Manager

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


Upload from your computer

Or import from cloud storage

Your Supporting Document must be a .doc, .pdf, .docx, .txt, .rtf, and no bigger than 8MB


4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from Fish4.co.uk by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on Fish4.co.uk you agree to our terms and conditions and privacy notice. You should never be required to provide bank account details. If you are, please email us.

More searches like this