Quality Assurance Associate (Medtech)

TL;DR

Quality Assurance Associate (Medtech): Ensuring compliance with FDA, ISO, and Canadian Medical Devices regulations for approved and developing products with an accent on documentation review and quality system adherence. Focus on managing quality events (CAPAs), performing root cause analysis, and driving continuous improvement of the Quality System.

Location: On-site in Cambridge, UK

Salary: £30,000 - £35,000 a year

Company

hirify.global, a subsidiary of OraSure Technologies Inc., develops innovative sampling tools and diagnostics to personalize healthcare and improve global health.

What you will do

• Review and approve documentation for raw materials and manufactured products to ensure Quality System compliance.
• Manage the archiving of Device History Records in accordance with document retention policies.
• Assist in handling quality events, including CAPAs and root cause analysis.
• Prepare and review documents and procedures supporting compliance with regulatory requirements.
• Evaluate Quality functions to facilitate continuous improvement of the Quality System.

Requirements

• Scientific degree.
• 0-2 years of experience in a regulated industry.
• Ability to work on-site in Cambridge, UK.
• Strong planning, organizational, and time management skills.
• Proficiency in Microsoft Office applications (Word, Excel, etc.).
• Strong written and oral communication skills.

Culture & Benefits

• Private health and dental insurance.
• Life insurance and pension scheme.
• Paid time off, including maternity and parental leave coverage.
• Employee referral program with potential cash bonuses.
• Access to internal committees (Wellness, Sustainability, Social) and mentorship programs.
• Free onsite parking.