Medical Device Quality Officer - Coventry - £35,000

ISL Recruitment
05 May 2017
04 Jun 2017
Contract Type
Full Time
Job Description

Reporting to
Quality and Regulatory Manager

Summary of Key Responsibilities and Role
The Quality Assurance Officer will report to the Quality and Regulatory Manager and will be based in the Coventry. The role will be responsible for supporting the Quality Management System in adherence to ISO13485, CFR Title 21 part 820 and other appropriate standards.
In addition, the role will, when required, assist in certain aspects of regulatory compliance and individual product filings.

This role offers an exciting opportunity with future expansion within the role itself

Principle Responsibilities - Quality

*Assist in the continuous improvement of the existing quality system.
*Ensure all documents and procedures are in place and kept current.
*Support the internal audit process and perform internal audits, along with management and implementation of corrective actions.
*Support the CAPA process, coordinating root causes and corrective actions for both in-house and customer returns and complaints, with follow up checks to verify implementation.
*Support in the management of supplied material quality issues. Ensure issues are effectively resolved and investigations are fully documented.
*Work with electronic document control system, contributing to the drafting of documentation, approval, reviewing and implementation of internal QMS documentation in accordance with ISO 13485, CFR Title 21 part 820 and MDD.
*Support change control and new product development by providing Quality Assurance expertise to ensure quality management system requirements are achieved.
*Be proactive to ensure changes to the relevant standards are adopted in a timely manner.

Secondary Responsibilities - Regulatory

*Support the Regulatory function in relation to both product certification and company compliance in accordance with ISO 13485, CFR Title 21 part 820 and the MDD.
*Support regulatory submissions within the EU.
*Review labelling and packaging components to ensure accuracy and compliance with various regional regulations.

Required Skills and or qualifications

*A level of education appropriate to the role.
*A strong medical device background
*Experience of working with an enterprise wide Quality System, ideally ISO 13485 and CFR Title 21 part 820.
*Experience of internal and external audit essential.
*Impartial and objective decision maker.
*Must have a "can do" attitude and be comfortable working in a small flexible and dynamic team.
*A working understanding of Microsoft Office suite.
*Must have a current and valid UK / European driving license.
*Experience of regulatory requirements and technical files would be beneficial.
*Eligibility to work in the UK

If you would like to be considered for this opportunity, please forward over your most recent CV for consideration and further details.

ISL (Incite Solutions Ltd) is acting as an Employment Agency in relation to this vacancy.