Quality Assurance Technologist (Medical Device)

Position Summary:

We are seeking a highly motivated and detail-oriented Quality Assurance Technologist to join our team. The role involves managing quality documentation, supporting internal audits and regulatory activities, and overseeing key quality system processes.

Key Responsibilities:

• Drafting, revising, and maintaining controlled documents, including procedures, work instructions, forms, and specifications.
• Supporting departments in the document change process, maintaining a centralized document index, and coordinating the release and distribution of new revisions.
• Planning and executing the annual internal audit program, including coordination and scheduling of audits, verifying internal auditor qualifications, reviewing and approving audit reports, and ensuring follow-up and closure of corrective actions across audited departments.
• Leading change control activities and maintaining oversight of change implementation and documentation.
• Managing the corrective and preventive action (CAPA) process, including investigations, root cause analyses, documentation, and closure tracking.
• Supporting regulatory inspections and certifications, preparing for and accompanying external audits, and generating quality performance reports and trend analyses.

Qualifications:

• Bachelor’s degree in a scientific discipline – required.
• Previous experience in quality assurance and familiarity with ISO13485 and 21 CFR Part 820 – strong advantage.
• High-level English proficiency across reading, writing, and speaking.
• Experience with SAP – an advantage.
• Proficiency in Microsoft Office, particularly Excel.
• Strong interpersonal skills with a proactive and assertive mindset.
• Team player with excellent collaboration and communication abilities.