Quality Manager – Medical Device Compliance Leader

Valid8 Financial, Inc.; Oak Creek (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

Valid8 Financial, Inc. is seeking a Quality Manager to lead daily quality operations in a medical device manufacturing setting in Oak Creek, WI. You will ensure products, processes, and documentation satisfy FDA, ISO 13485, and internal quality system requirements.

You will oversee quality inspectors/technicians, support production, drive compliance, and maintain audit readiness, while mentoring staff and leading continuous improvement initiatives to reduce defects.

Qualifications

• Bachelor’s degree in Quality, Engineering, Life Sciences, or related field preferred; equivalent experience accepted.
• 3+ years of experience in quality assurance within medical device, pharmaceutical, or regulated manufacturing.
• 1+ years of leadership or supervisory experience.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and GMP principles.
• Experience with inspection tools, measurement systems, and quality documentation.

Responsibilities

• Leads daily quality operations in a medical device manufacturing environment.
• Manages quality inspectors/technicians, including scheduling and performance management.
• Ensures in-process and final inspections are completed accurately and on time.
• Reviews and approves inspection records, DHRs, and nonconformance reports.
• Supports investigations, root cause analysis, and CAPA activities.
• Drives continuous improvement to reduce defects and improve process capability.

Skills

Quality leadership

Document control

Communication

Problem solving

Coaching

Conflict resolution

Education

Bachelor's degree in Quality/Engineering/Life Sciences

Tools

eQMS (MasterControl/Greenlight Guru)

MS Office

Inspection tools

Job description

Valid8 Financial, Inc. is seeking a Quality Manager to lead daily quality operations in a medical device manufacturing setting in Oak Creek, WI. You will ensure products, processes, and documentation satisfy FDA, ISO 13485, and internal quality system requirements.

You will oversee quality inspectors/technicians, support production, drive compliance, and maintain audit readiness, while mentoring staff and leading continuous improvement initiatives to reduce defects.