Mike Miller Email & Phone Number

Perform onsite and remote quality system gap assessments and remediations per FDA 21 CFR 820, ISO 9001, and ISO 13485.Interim onsite Quality Director for Medical Device Start Up Company. Mentor quality and design control teams. Participated in onsite FDA inspection with no 483 observations. Configured, maintained, and resolved technical issues with MasterControl Quality Management software system for dietary supplement manufacture. Assisted project teams and process owners from multiple sites in the initiation and planning phases of module implementation for documents, training, supplier management, internal audit, complaints, CAPA, non-conformance, and deviation,

Responsible for client relations, develop statement of work, resource selection and deployment, budget monitoring, and program risk management.

Greater Chicago Area

Responsible for directing and managing compliance at the divisional level for product life cycle, design control and CAPA in support of disposable medical devices.

Greater Chicago Area

Managed engineers and technicians supporting design engineering groups responsible for the design and product launches of medical devices.

Greater Chicago Area

Acted as quality representative assuring new and modified designs were created and developed in conformance to established standards. Perform CAPA activity.

Greater Chicago Area

Led multiple cross functional teams in a variety of disposable medical device new design product launches, product redesigns, and quality improvements. Developed medical device designs, created requirements documents, developed test procedures, and coordinated design testing.

Greater Chicago Area

Planned and managed all work activities of inspectors and technicians.

Greater Chicago Area

Audited suppliers for compliance to regulations and standards.

Mba, Operations Management

Bs, Industrial Technology

Associate’S Degree