Quality Assurance Associate (Medical Devices)

Location: Fully onsite in Wotton, Surrey, United Kingdom

Company

hirify.global provides customer-focused life sciences and manufacturing services driven by innovation, collaboration, accountability, and quality.

What you will do

• Gatekeep the document control process and ensure timely training on new and updated procedures.
• Create and progress document-related change controls.
• Conduct internal audits across both manufacturing locations and recommend corrective actions.
• Host customer audits and coordinate cross-functional responses to findings.
• Prepare for and participate in certification body audits against ISO 9001 and ISO 13485 requirements.
• Monitor quality indicators and trends, report findings to senior leadership, and identify quality-related training needs.

Requirements

• Bachelor’s or Associate Degree in Education, Life Science, Science, Chemistry, Business, Engineering, or a related field.
• At least two years of experience in quality assurance or a related field.
• Working knowledge of change control, document control, and resolving nonconforming outputs through the 8D corrective action methodology.
• Ability to understand complex life sciences and medical device documentation, including QM, DHF, DMR, DHR, PMS, IFUs, and PSURs.
• Proficiency with Windows, Microsoft Office, Teams, Excel, Visio, and related task-management applications.
• Ability to manage multiple projects, facilitate training and presentations, and collaborate with senior leadership, manufacturing, engineering, and global teams.

Nice to have

• Internal Auditor experience.
• Willingness to obtain and maintain Lead Auditor Certification.

Culture & Benefits

• Customer-focused culture encouraging innovation and challenging the status quo.
• Collaborative work relationships across departments and global teams.
• Core values include Customer Focus, Achievement, Accountability, Teamwork, Employee Value, and Integrity.