Quality Manager

MRA Recruiting Services; Menomonee Falls (WI); On-site; USD 100,000 - 110,000; Full time

Job summary

Addev Materials Healthcare (AMH) in Menomonee Falls, WI, is seeking a Quality Manager to lead the quality function in a growing medical manufacturing environment. You will drive product quality, process effectiveness, and continuous improvement, serving as the primary quality contact for customers and suppliers while overseeing audits and regulatory activities.

You will mentor a quality team, foster accountability and compliance, and use data-driven decision making to reduce risk, improve

Qualifications

• 5+ years of quality leadership in a regulated manufacturing environment.
• Deep expertise with ISO 13485 and leading audits.
• Hands-on experience with risk-based quality tools (FMEA, Validation, SPC).
• Strong customer-facing communication supporting audits, investigations, and regulatory compliance.

Responsibilities

• Lead the quality function and mentor the quality team.
• Collaborate cross-functionally to improve product quality and process effectiveness.
• Oversee external audits and regulatory activities.
• Apply data-driven decision making to reduce risk and improve operational performance.

Skills

Quality leadership

Cross-functional collaboration

Regulatory compliance

Customer-facing communication

Tools

FMEA

SPC

Validation

Job description

Lead Quality Excellence Across a Growing Medical Manufacturing Environment

Company: Addev Materials Healthcare (AMH)

Role: Quality Manager

Location: Menomonee Falls, WI

Schedule: Monday through Friday, 8 AM to 4:30 PM, on-site

Salary Range: $100K to $110K

In this highly visible role, collaborate cross-functionally with various departments to drive product quality, process effectiveness and continuous improvement across the organization. Serve as the primary quality contact for customers and suppliers, oversee audits and regulatory activities, and leverage data-driven decision-making to reduce risk, improve consistency, and enhance operational performance. As leader of the quality team, develop and mentor team members while fostering a culture of accountability, compliance, and quality excellence.

The Ideal Candidate Will Have

• 5+ years of quality leadership experience in a regulated manufacturing environment
• Deep expertise with ISO 13485, proven success improving Quality Management Systems and leading audits
• Hands-on experience with risk-based quality tools (FMEA, Validation, SPC)
• Strong customer-facing communication skills supporting audits, quality investigations, and regulatory compliance.