Quality Control Manager: Lead, Compliance & Innovation

RAPS Institute; Waukesha (WI); On-site; USD 90,000 - 150,000; Full time

Job summary

Werfen is seeking a Manager, Quality Control to lead the QC team within the Transplant Technology Center. You will drive strategic direction, ensure adherence to SOPs and regulatory requirements (FDA, ISO 13485, 21 CFR 820, MDSAP), and partner with QA, RA, R&D, and Manufacturing to support product development and release.

This role emphasizes building a high-performing, compliant team, overseeing CAPA, NCR investigations, KPI tracking, budget adherence, and continuous process improvement while

Qualifications

• Bachelor’s Degree in Medical Technology or a related field.
• Minimum 7 years of clinical laboratory experience with in-vitro diagnostics; preferred HLA screening and Elisa products.
• Minimum 5 years of people management experience in a clinical or GMP environment.

Responsibilities

• Leads the Quality Control team with strategic direction and SMART goals.
• Ensures adherence to SOPs, FDA, ISO 13485, 21 CFR 820, and MDSAP standards and GMP practices.
• Drives continuous process improvements and operational efficiency across QC operations.
• Manages department budget, equipment purchases, and training.
• Presents KPI metrics at QRB and MRB; leads investigation governance (OOS, CAPA, NCR).
• Authors and updates SOPs, FORs, and TMPs; supports validation plans and PDP projects.
• Oversees QC planning, scheduling, and the QC Stability Program.

Skills

Leadership

Communication

Strategic thinking

Problem solving

Organization

Coaching

Continuous learning

Time management

Conflict resolution

Education

Bachelor's Degree in Medical Technology or related field

Job description

Werfen is seeking a Manager, Quality Control to lead the QC team within the Transplant Technology Center. You will drive strategic direction, ensure adherence to SOPs and regulatory requirements (FDA, ISO 13485, 21 CFR 820, MDSAP), and partner with QA, RA, R&D, and Manufacturing to support product development and release.

This role emphasizes building a high-performing, compliant team, overseeing CAPA, NCR investigations, KPI tracking, budget adherence, and continuous process improvement while