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, seeks a Quality Manager to lead the quality function in a growing medical manufacturing environment. You will drive product quality, process effectiveness, and continuous improvement while serving as the primary quality contact for customers and suppliers.

Audits, regulatory activities, and data-driven risk reduction are key focus areas. The ideal candidate has 5+ years of quality leadership in regulated manufacturing, deep ISO 13485

Qualifications

• 5+ years of quality leadership experience in a regulated manufacturing environment.
• Expertise with ISO 13485 and leading audits.
• Hands-on experience with risk-based quality tools: FMEA, Validation, SPC.
• Strong communication with customers for audits and regulatory compliance.

Responsibilities

• Drive product quality, process effectiveness and continuous improvement across the organization.
• Serve as primary quality contact for customers and suppliers, overseeing audits and regulatory activities.
• Leverage data-driven decision-making to reduce risk, improve consistency and operational performance.
• Develop and mentor the quality team, fostering accountability and a culture of quality excellence.

Skills

Quality leadership

ISO 13485

FMEA/Validation/SPC

Customer-focused communication

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

The Role

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