Senior Quality Lead Medical Devices Compliance

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

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