Job Title: Quality Assurance Specialist
Key Responsibilities:
• Review and approve product labels for accuracy and compliance.
• Populate and review Instructions for Use (IFUs) with technical data.
• Maintain and update IFU templates to ensure consistency.
• Enter and verify data in the Technical Library (XML files).
• Process label updates through document control systems.
• Assist with master labelling documents, including labels, IFUs, and packaging specs.
• Support validation activities for auto-population systems.
• Upload approved documentation to internal and customer-facing platforms.
• Adhere to SOPs and regulatory requirements.
Qualifications and Skills:
- Level 5 qualification in Science, Engineering, Pharma, or QA (desirable).
- 2+ years' experience in a regulated medical or diagnostics setting.
- Familiarity with Microsoft Word and Excel; knowledge of Adobe InDesign and NiceLabel Pro is a plus.
- Basic understanding of regulatory frameworks like FDA 21 CFR Part 820, ISO 13485, and IVDR.
Benefits and Perks:
- 25 days annual leave.
- Health allowance and life assurance.
- Retail discounts (local and national).
- Free Employee Assistance Programme.
- Recognition and reward schemes.
- Ongoing career development and progression opportunities.
Company Culture:
- Diverse perspectives lead to better outcomes.
- Encouragement of applicants from all backgrounds.
- Equal opportunity employer with reasonable accommodations for individuals with disabilities.