Accordance Search Group
Sr. Quality Assurance Engineer
Accordance Search Group, Indianapolis, Indiana, United States, 46201
Our client is seeking a highly skilled and experienced Senior Quality Engineer to join our Quality Assurance team in
Fishers, Indiana.
The ideal candidate will possess a deep understanding of quality engineering principles, regulatory requirements, and risk management processes applicable to the medical device industry. This role requires a proactive individual who is capable of leading quality initiatives, driving continuous improvement, and ensuring compliance with both internal and external standards across cross functional teams.
PRIMARY OBJECTIVES & AUTHORITY:• Implement and maintain 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.• Provide training and guidance to team members
SKILLS, KNOWLEDGE AND EXPERIENCE:• 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
Fishers, Indiana.
The ideal candidate will possess a deep understanding of quality engineering principles, regulatory requirements, and risk management processes applicable to the medical device industry. This role requires a proactive individual who is capable of leading quality initiatives, driving continuous improvement, and ensuring compliance with both internal and external standards across cross functional teams.
PRIMARY OBJECTIVES & AUTHORITY:• Implement and maintain 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.• Provide training and guidance to team members
SKILLS, KNOWLEDGE AND EXPERIENCE:• 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