Sr. Quality Assurance Engineer

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