Quality Management System Administrator

Quality Management System Administrator

Location: Coventry, CV3 2RQ
Salary: Competitive, DOE + Benefits
Contract: Full Time, Permanent
Hours: Full Time, 37.5 per week

Quality Management System Administrator- Benefits:

• Competitive salary
• Contributory pension scheme
• Life cover
• Incapacity benefits
• Cash Back Medical Scheme

SFM is an innovative medical devices manufacturer of advanced wound care products, including combination products, from gelling fibres and fabrics. We deliver innovative, cost effective and quality products and solutions for the advanced wound care industry helping to improve patient care and wellbeing.

Currently an exciting opportunity has arisen for a motivated and dynamic QMS Administrator to join and support RAQ team.

Quality Management System Administrator- The Role:

The role is responsible for supporting the Quality Management System within the business, ensuring compliance to ISO 13485 and 21 CFR 820 requirements.

The key purpose of the role will be to work closely within the Quality department to develop and deliver a range of proactive and responsive QMS initiatives including the management of the systems for: documents control, equipment monitoring and calibration and manufacturing batch history records review.

This is a junior role and would suit someone who would like to get more experience within Quality Management Systems and Quality Department.

Key Tasks and Responsibilities:

• Review and manage the manufacturing/production batch history records to ensure Good Documentation Practices
• Co-ordinate equipment calibration
• Manage, co-ordinate document control within the business via use of the electronic document control system, contributing to the drafting of documentation, managing the review and approval of documents including procedures, SOPs, WIs, and forms within the SFM QMS
• Support internal audits as an internal auditor, along with management of corrective actions
• Support the delivery of the non-conformance and CAPA Management System in the business
• Champion compliance to all applicable standards, regulations and internal procedures by proactively interpreting quality and regulatory requirements and implementing solutions
• Work within the Quality department to promote continuous improvement and ensure compliance with quality policies across the business
• Demonstrate the values of the team and be a Quality Champion in the business

Quality Management System Administrator - Key Skills / Abilities:

• Scientific degree or equivalent
• Experience of working to or in an ISO 9001, ISO 13485 or 21 CFR 820 QMS environment
• Experience of document control management in a relevant environment; desirable if in the medical device industry
• Able to get on with and influence people both internally and externally to achieve objectives
• Able to work with minimum supervision and as part of a team
• Strong communication skills both verbal and written
• Flexible attitude and capable of working under pressure to tight and constantly changing deadlines

If you have the skills and experience we require for this role and are looking for a new challenge, please Click on Apply and forward your CV to us with a relevant cover letter, explaining why you are a good fit for this role.

Due to the number of applications we receive, we will only contact those candidates that we want to take forward to interview; if you do not hear from us within 4 weeks, please assume that your application has been unsuccessful on this occasion.

No agencies please.