Quality Assurance Manager - Indianapolis, Indiana

Medical Device Manufacturing

As the Quality Assurance Manager you will support daily operations to ensure the company's regulatory compliance, quality practices and continued growth. You will manage the activities related to cGMP manufacturing, packaging, testing, and storage, as well as participating in the relevant audits. In this role you will need to work cross-functionally with Operations, Engineering, Distribution, R&D, Marketing, Sales, and other team members, to ensure the quality management system (QMS) is organized, efficient, and compliant with Food and Drug Administration (FDA) requirements and that QA/QC processes are compliant with all relevant regulations and business policies/practices. You will manage department staff reviews and annual performance goals. More details available upon request.

Requirements:

• 8 years of experience in Quality Assurance, with preference for medical device or related experience
• Bachelor's degree in Sciences, Engineering or another technical field
• Direct experience in manufacturing
• Perform as a coach / mentor to the team and others on staff
• Strong working knowledge of quality systems and regulatory compliance in medical devices, FDA and ISO standards.
• Must have experience with QMS and ISO (implementation experience would be a plus)

Any of the following Certifications would be a plus:

• Certified Quality Auditor (CQA)
• Certified Quality Engineer (CQE)
• Certified Quality Manager (CQM)