Job Title:
Quality Assurance (QA) Technician
Role Overview
The QA Technician is responsible for providing daily quality support to manufacturing operations to ensure that processes remain effective, compliant, and continuously improved. The role focuses on production auditing, managing non-conforming materials, quality metrics reporting, and ensuring adherence to Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP).
This position plays an integral role in supporting the manufacture of innovative medical devices in compliance with international quality and regulatory standards, including ISO 13485, FDA 21 CFR Part 820, and EU Medical Device Regulation (MDR).
Key Responsibilities
* Provide day-to-day quality support for manufacturing operations to maintain effective and compliant processes.
* Participate in daily and weekly production meetings, offering quality insights and updates.
* Conduct audits on production processes, incoming inspections, and documentation to verify compliance with established procedures.
* Support and promote adherence to Good Documentation Practices (GDP) across all manufacturing documentation.
* Manage non-conforming materials, ensuring timely segregation, control, and disposition.
* Participate in corrective and preventive actions (CAPA) and perform root cause analysis for identified non-conformances.
* Prepare, track, and report quality metrics and contribute data to management review activities.
* Support product rework processes as needed.
* Maintain work areas and equipment to ensure a clean, safe, and compliant environment.
* Contribute to the creation, review, and approval of work instructions, visual aids, and test documentation.
* Initiate and review Document Change Notifications (DCNs) related to manufacturing processes.
* Collaborate with cross-functional teams during process validations, engineering builds, and product transfers.
* Drive continuous improvement through lean and Six Sigma methodologies.
* Support internal and external audits, including preparation of production areas and relevant documentation.
Qualifications and Experience
Education:
* Bachelor's degree or equivalent qualification in a Quality, Engineering, or Science-related discipline.
Experience:
* 2–5 years of experience in a quality or operations role within the medical device or pharmaceutical industry.
* Strong understanding of ISO 13485, EU MDR, and FDA quality system requirements.
* Proven experience writing and managing documentation in a regulated environment.
* Experience conducting audits in compliance with quality and regulatory standards.
Skills and Competencies
* Excellent written and verbal communication skills.
* Strong problem-solving and analytical abilities.
* Ability to work independently and collaboratively in a team-oriented environment.
* Effective task prioritization and time management skills.
* Familiarity with cleanroom manufacturing processes and documentation standards.
* Proficient in Microsoft Office applications (Word, Excel, PowerPoint).
* Strong attention to detail and commitment to quality and compliance.