Senior Quality Systems Administrator (12 month FTC)

at  Endomag

QUALIFICATIONS

• Previous experience of configuring eQMS systems or systems platforms within a pharmaceutical or Medical Device environment is the major consideration.
• Experience with pharmaceutical or medical device Quality administration is advantageous.
• Degree or equivalent in computing/engineering/Life Science or closely related field.

EXPERIENCE AND KNOWLEDGE

• 1-5 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) are required.
• Experience configuring eQMS and implementing electronic systems is preferred.
• Experience with validation of software platforms is desirable but training will be given.

ABILITIES AND SKILLS

• Self-starter with strong motivational skills.
• Good written skills, demonstrated in a range of contexts.
• Evidence of effective communication and interpersonal 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

THE PURPOSE OF THE ROLE:

The main function of this role is to ensure ongoing improvement of the eQMS and continued compliance. Other functions within this role will involve support functions to the Quality and Regulatory team, liaising with various departments in a busy and dynamic environment.

KEY RESPONSIBILITIES AND DUTIES:

• Responsible for the company’s electronic ISO 13485 quality system, providing ongoing maintenance, configuration and implementation of new processes, and validation activities.
• Support in 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.
• Maintenance of documentation for future products related to quality assurance processes and maintain records for compliance and auditing purposes.
• Support and maintain the release process, for new product release to customers, logging and maintenance of repairs and complaints and associated tasks.
• Support the QA Director and QA/RA Compliance Manager during audits by Notified Body or other organisations as required.