Senior Quality Assurance Specialist

2 weeks ago


Marquand, Missouri, United States Accordance Search Group Full time
Senior Quality Assurance Engineer

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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