Quality Systems Analyst
Medical Devices
Plymouth
Permanent Contract
Focus of the role
Principally to manage and control quality system documentation and eQMS consisting of Standard Operating Procedures, drawings, work instructions, procedures, material specifications, product specifications, artwork, and other various documents such as deviations, change control and document control. Responsible for the management of the Quality Management document control system (including eQMS). Performing Internal Audits and maintaining resultant reports. Issuing and verifying corrective and preventative actions.
Role Responsibilities
- Responsible for understanding the company quality policy and performing functions in accordance with documented quality procedures.
- Perform all document and record responsibilities including change control.
- Establish support and awareness to change requestors in defining changes, evaluating the impact.
- Review completeness of documentation ensuring compliance to all relevant requirements.
- Facilitate implementation assessments to determine document control and training impact to ensure right first time.
- Support and train new employees to DCO and change control process.
- Provide documents as required timely distribution of latest revision.
- Acts as SME for document, record and change control process.
- Set up, scan, copy and store/archive.
- Create templates.
- Manage request for documents and change control.
- File in physical and digital records, ensure appropriate storage.
- Review and maintain the accuracy of records, editing where necessary to ensure they are up to date.
- Distribute project related information with all levels of the project team.
- Manage the process around documentation within organisation.
- Prepare ad hoc reports when required.
- Conform to requirements of GMP.
- Communicate with other functions.
- Ensure timely release of documentation.
Qualification & skills
- Requires high school diploma or equivalent, or relevant industry knowledge and experience.
- Good mathematical and reasoning ability.
- Ability to read and interpretate documentation.
- Knowledge of manufacturing and quality systems.
- GMP experience strongly preferred. Experience of quality documentation review advantageous.
- Good organisation/time management skills, ability to prioritize and ability to multi - task.
- Strong attention to detail.
- Strong verbal and written communication skills, with ability to interact with all levels of the organisation.
- Challenges status quo and initiates improvements.
- Advanced computer skills - including high level of Microsoft Office including Excel, Word, Outlook, PowerPoint, Docusign, Adobe and Adobe Editor an advantage.
- Knowledge and experience of regulatory systems and approvals including MDR and ISO 13485 an advantage.
Salary & Benefits
£25,000 per annum
You'll receive a fantastic benefits package including pension scheme, Private Medical, healthcare cover, life assurance, and much more!