Key Responsibilities

• Primary Administrator for the company’s electronic ISO 13485 quality system, providing ongoing maintenance and validation activities.
• Documentation control to ensure implementation of changes to procedures within the QMS and technical files as standards evolve
• Ensure effective maintenance of the company’s training records
• Assist in managing quality procedures across supply chain partners and manufacturers to ensure maintenance of standards
• Assist the team to ensure quality audit actions are completed in a timely manner
• Manage customer tracking as it relates to quality of products and post-market surveillance

Individual Specification

Qualifications

• Experience in QA/QC administration is the major consideration

Experience and Knowledge

• 2-5 years experience in ISO quality systems for pharmaceutical or, ideally, medical devices
• Evidence of experience working in a busy and demanding environment within a team and individually
• Good IT skills (MS Office)
• Experience with validation of software platforms is desirable but training will be given.

Other

• Willingness to occasionally travel within the UK

Abilities and Skills

• Self-starter with strong motivational skills
• Good written skills, demonstrated in a range of contexts
• Evidence of effective communication and inter-personal skills
• Evidence of ability to work with critical attention to detail and high levels of accuracy
• Proven organisational and time management skills to effectively handle conflicting priorities and ensure tight deadlines are met
• Experience in working for a small, dynamic organisation

 

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Applications

To apply for this role, please email your CV/resume and a cover letter to:

recruitment@endomag.com