Overview
The Quality Assurance & Compliance Assistant will play a vital role in ensuring adherence to quality standards and regulatory compliance within a specialist healthcare and biomedical technology company. This position involves providing essential support in quality assurance, document management, and administrative tasks while collaborating closely with the Quality and Product teams. The role offers a choice between a full-time fixed-term contract or a flexible day rate, both operating on a hybrid model with one day on-site per week in the Burton upon Trent area.
Responsibilities
- Maintain and update quality documentation within the company's Quality Management System (QMS).
- Help schedule and coordinate internal audits and external regulatory reviews.
- Support compliance activities aligned with ISO 13485 and regulatory standards.
- Review and address non-conformances and Corrective and Preventive Actions (CAPAs).
- Conduct quality checks and approve purchase orders and certificates of conformance.
- Assist with collating environmental, social, and governance (ESG) records and tracking metrics.
- Produce basic reports to support compliance and quality objectives.
- Provide general administrative assistance across the Burton office, including onboarding training records and supplier reviews.
Requirements
- Strong attention to detail and good analytical skills.
- Solid written and verbal communication abilities.
- Prior experience in Quality Assurance (QA), document control, or a regulated environment is advantageous.
- Familiarity with standards such as ISO 9001/13485, life sciences, or pharmaceuticals is a plus.
- Ability to commit to one day per week in the Burton upon Trent office.
- Organised, proactive, and self-motivated.