Senior Quality Assurance Specialist
2 weeks ago
We are seeking a highly skilled and experienced Senior Quality Assurance Engineer to join our Quality Assurance team at Accordance Search Group in the medical device industry.
Key Responsibilities:
• Develop and implement quality management systems (QMS) in accordance with ISO 13485, FDA regulations, and other applicable standards.
• Lead root cause analysis and corrective action/preventive action (CAPA) investigations for non-conformities and quality issues.
• Collaborate with cross-functional teams to ensure quality considerations are integrated into product development and manufacturing processes.
• Perform internal audits and support external audits, ensuring compliance with regulatory requirements and company policies.
• Participate in Change Control process.
• Analyze quality metrics and trends to identify areas for improvement and drive continuous quality improvement initiatives.
Requirements:
• 5- 10 years' experience as a Quality Engineer/Specialist with strong knowledge and understanding of the practical implementation of ISO13485 and FDA CFR 21 part 820
• Strong QMS auditing skills
• Working knowledge of Good Manufacturing Practice (GMP)
• High level skills in using Microsoft Office Suite
Education / Qualifications:
• Bachelor's in engineering, or equivalent qualification in engineering or a related scientific discipline
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