Quality Assurance Specialist

As a QA Specialist, you will be responsible for maintaining the quality of medical products by establishing quality standards and conducting inspections. Additionally, you will support quality system implementation, oversee compliance with regulatory requirements, and collaborate with cross-functional teams to drive continuous improvement.

Key Responsibilities:

• Perform quality inspection with specified requirements.
• Maintain and manage the applicable procedures and instruction, including Device Master Documents.
• Support and provide inputs to product-related issues such as nonconformance, complaint, CAPA and supplier CAPA.
• Oversee the equipment calibration and maintenance program, as well as storage environment data monitoring.
• Assist in developing required documentation or justification to support proposed product related changes initiated by R&D and/or contract manufacturer.
• Conduct and support supplier audit, internal and external quality system audits.
• Contribute to quality system implementation projects.
• Participate in new or modified product development projects and support deliverables required for each design phase.
• Participate in risk management activities such as verification of risk mitigation implementation in products and processes.
• Perform other duties as assigned.

Qualifications:

• Bachelor's degree in Engineering, Quality Assurance, Life Sciences, or a related field.
• Minimum 2-3 years of experience in quality assurance, regulatory compliance, or manufacturing in the medical device or related industry.
• Previous experience and familiarity in ISO 13485, FDA regulations, and ISO 14971 for medical devices is an advantage.
• Computer literate in Microsoft Office.
• Self-motivated and proactive, with a strong sense of initiative and ownership to drive departmental and organizational goals.
• Strong attention to detail and problem-solving skills.
• Effective communication skills to interact with cross-functional teams and suppliers.