Quality Assurance Associate

Quality Assurance & Document Control

Dorking, Surrey

Fully on site

Permanent £25,000 - £30,000

We're looking for a Quality Assurance & Document Control professional to support and enhance the Quality Management System across multiple manufacturing facilities.

Working closely with the wider Quality team, you'll help maintain compliance with FDA Quality System Regulations while ensuring alignment with ISO 9001 and ISO 13485 standards.
This role requires autonomy, strong organisational ability, and the confidence to lead audits at various levels.

Key Responsibilities

Conduct routine internal audits across manufacturing sites
Assess processes, procedures, and documentation against internal quality standards
Identify improvement opportunities and recommend corrective actions
Host and support customer audits
Coordinate cross-functionally to gather information and address findings
Maintain strong customer relationships throughout the audit process
Prepare for and participate in ISO 9001 / ISO 13485 certification audits
Ensure compliance across all required areas
Work with relevant departments to resolve non-conformities
Track quality performance indicators and trends
Present findings to senior leadership
Identify training gaps and support quality-related training initiatives
Communicate effectively with leadership, colleagues, and global teams
Collaborate with Engineering, Manufacturing, and other functions to uphold quality standards Requirements

Excellent written and verbal communication skills
Experience in document control and change control

Experience with batch/product release processes
Strong knowledge of Microsoft Office and quality-related software/tools
Understanding of audit methods and inspection processes
Knowledge of:
ISO 14971 (risk management for medical devices)
IEC 62304 (medical device software)
GxP, GMP, FMEA, HACCP
Relevant medical device & pharmaceutical standards

Qualifications

Bachelor's or Associate Degree in:
Life Science, Chemistry, Engineering, Business, Science, or related field
Ability to obtain/maintain Lead Auditor Certification (ISO 19011 or similar)
Minimum:
Bachelor's degree + experience in Life Sciences, Medical Devices, or similar regulated industries
At least 2 years' experience in quality assurance or related field
Working knowledge of:
Change Control
Document Control
8D corrective action methodology
Ability to understand complex documentation such as:
QM, DHF, DMR, DHR, PMS, IFU, PSUR, etc.
Strong organisational and project coordination skills
Proficient with Windows, MS Office (Teams, Excel, Visio), and task-tracking tools (Planner, To Do, etc.)
Strong teamwork skills and ability to deliver training/presentations at all levels