Manager of Quality Assurance (Bloomington)

Notice : MCRAs Talent Solutions division works to unite top talent with opportunities on our clients teams. This posting is not for a position directly at MCRA, but rather for a position with an MCRA client that our team is helping to recruit and fill.

MCRA Talent Solutions is proud to partner with an emerging MedTech startup advancing AI-driven neurotechnology to support individuals with neurological conditions. Their wearable therapeutic has recently received FDA clearance. Additionally, their implantable technology has been recognized with multiple FDA breakthrough designations for its potential in intuitive device interaction and pain management. We are looking to identify a Manager of Quality Assurance to join this growing team who will be responsible for leading and evolving the companys quality systems across both pre-market and post-market phases.

Key Responsibilities

• Develop, implement, and maintain design controls , risk management (ISO 14971), and product development documentation in accordance with 21 CFR 820 and ISO 13485.
• Ensure effective design transfer to manufacturing and supplier quality oversight.
• Support clinical and regulatory teams with quality documentation for FDA, CE, and other submissions.
• Manage quality inputs during product development, including verification / validation protocols, usability studies, and labeling reviews.
• Oversee complaint handling, investigation, and Medical Device Reporting (MDR).
• Manage CAPA processes, including root cause analysis and effectiveness checks.
• Lead post-market surveillance activities, including trend analysis and risk re-evaluation.
• Support audits and regulatory inspections by FDA, Notified Bodies, or other agencies.
• Maintain and improve the companys Quality Management System (QMS).
• Lead internal audits and train teams on quality procedures and compliance culture.
• Evaluate and implement eQMS tools for scalable documentation control and traceability.
• Collaborate cross-functionally with R&D, clinical, operations, and regulatory teams.

Qualifications

Compensation and Benefits :