Quality Assurance Specialist
About The Position
We are seeking a detail-oriented and motivated Quality Assurance Specialist to join our Quality & Regulatory Affairs team. This role plays a critical part in ensuring our medical devices continue to meet the highest standards of quality, safety, and regulatory compliance while supporting the successful growth of our manufacturing operations and product portfolio. The ideal candidate enjoys working cross-functionally, has strong organizational skills, and is passionate about maintaining quality systems that enable innovative medical technologies to reach healthcare providers and patients around the world. Reporting to the Quality & Regulatory Affairs Manager, you will work closely with Engineering, Manufacturing, Operations, and Regulatory Affairs to support both ongoing production and new product development initiatives.
Requirements
- Bachelor's degree in Science, Technology, Engineering, Mathematics (STEM), or a related discipline.
- Approximately one year of experience working in a regulated industry such as medical devices, pharmaceuticals, or biotechnology.
- Working knowledge of ISO 13485 and ISO 14971.
- Experience supporting quality systems within a manufacturing environment.
Nice To Haves
- Post-graduate education in Biomedical Engineering, Quality Assurance, Regulatory Affairs, or a related field.
Responsibilities
- Support and maintain the Quality Management System (QMS) in accordance with company procedures and applicable regulatory requirements.
- Assist with training documentation and quality records.
- Support Corrective and Preventive Action (CAPA) activities.
- Participate in change control processes.
- Manage complaints and product feedback documentation.
- Assist with internal and external quality audits.
- Review manufacturing documentation and production records.
- Perform quality control inspections of finished products.
- Review and release medical device products for distribution.
- Analyze manufacturing quality data to identify trends and opportunities for improvement.
- Support validation and ongoing maintenance of manufacturing equipment, software, and production processes.
- Support quality activities related to new product introductions and engineering design changes.
- Review verification and validation protocols and reports, risk management documentation, product requirements, specifications, and technical documentation.
- Maintain Design History Files (DHF) and Device Master Records (DMR).
- Collaborate with Engineering to ensure design changes are successfully transferred into manufacturing.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
