Quality Manager

ADDEV Materials Healthcare; Milwaukee (WI); On-site; USD 90,000 - 130,000; Full time

Job summary

ADDEV Materials Healthcare is seeking an experienced Quality Manager to lead the QMS, ensuring ISO 13485 compliance and alignment with customer specifications. You will drive continuous improvement, oversee audits, and provide technical leadership across quality functions in a manufacturing setting.

The role focuses on risk-based quality management, supplier quality, and collaboration with engineering and operations to improve processes and product quality. On-site in Wisconsin.

Qualifications

• 5+ years of quality experience in a regulated manufacturing environment.
• Strong knowledge of ISO 13485 and its application within a supplier environment.
• Experience with risk‑based quality tools (FMEA, control plans, validation, SPC).
• Demonstrated success driving QMS improvements and leading audits.
• Strong analytical, problem‑solving, and decision‑making abilities.
• Excellent communication skills with ability to interface directly with customers and regulatory auditors.
• Proficiency in Microsoft Office applications; experience with ERP/QMS software preferred.

Responsibilities

• Lead Quality Management System (QMS) leadership and continuous improvement initiatives.
• Oversee quality assurance activities and regulatory compliance (ISO 13485, 21 CFR 820 if applicable).
• Manage nonconforming product processes, CAPA, and risk management activities.
• Support equipment qualification, process validation, and ongoing process monitoring.
• Develop and implement quality improvement projects to reduce waste and improve product quality.
• Interact with customers and regulatory auditors as the primary quality contact.
• Supervise and develop quality technicians and support staff.

Skills

Quality management

ISO 13485

FMEA

Control plans

Process validation

SPC

Audits

Analytical skills

Communication skills

Microsoft Office

Tools

ERP software

QMS software

Job description

Location: On-site in Menomonee Falls, WI

Shift: Monday-Friday, 8:00am-4:30 pm

Position Summary

The Quality Manager is responsible for leading the Quality Management System (QMS) and ensuring that all products, materials, and processes meet applicable requirements for ISO 13485, customer specifications, regulatory expectations, and internal quality standards. This role drives ongoing QMS improvement initiatives, oversees quality assurance activities, and provides technical leadership for all quality‑related functions.

Essential Duties and Responsibilities

Quality Management System (QMS) Leadership

• Maintain, improve, and standardize the QMS in alignment with ISO 13485 and customer regulatory requirements.
• Lead continuous improvement initiatives focused on risk reduction, process capability, documentation effectiveness, and operational excellence.
• Oversee metrology, training, document control, corrective action processes, change control, and quality record retention.
• Prepare for and lead internal audits, supplier audits, and customer or notified body audits.
• Ensure that QMS metrics, KPIs, and quality objectives are established, monitored, and communicated.

Quality Assurance & Regulatory Compliance

• Ensure that all production, inspection, and documentation activities meet ISO 13485, customer‑specific, and applicable regulatory requirements.
• Manage nonconforming product processes including containment, disposition, root cause analysis, and corrective/preventive action.
• Lead risk management activities using tools such as FMEA, control plans, and process validations.
• Support equipment qualification, process validation, and ongoing process monitoring.

Continuous Improvement & Process Effectiveness

• Develop and implement quality improvement projects to reduce waste, improve consistency, and enhance product quality.
• Partner with engineering and operations to improve converting, slitting, printing, and laminating processes related to adhesive tape products.
• Drive reduction of scrap, variability, customer complaints, and internal defects.
• Utilize statistical analysis and data‑driven decision making to identify opportunities for improvement.

Supplier Quality Management

• Evaluate, approve, and monitor suppliers of adhesive materials, liners, inks, coatings, and outsourced services.
• Conduct supplier audits and lead supplier improvement initiatives.
• Establish clear quality expectations and ensure incoming materials meet specifications.

Customer Interaction & Technical Support

• Serve as the primary quality contact for medical device customers, supporting audits, documentation and regulatory requests, and complaint investigations.
• Lead the creation and submission of PPAP/FAI/qualification documentation as required by customers.
• Communicate quality performance, improvements, and issue resolutions clearly and professionally.

Leadership & Team Development

• Supervise, train, and develop quality technicians, inspectors, and support staff.
• Build a culture of accountability, continuous improvement, and quality ownership across all departments.
• Ensure consistent application of quality policies and procedures throughout the organization.

Required Qualifications

• 5+ years of quality experience in a regulated manufacturing environment.
• Strong knowledge of ISO 13485 and its application within a supplier environment.
• Experience with risk‑based quality tools (FMEA, control plans, validation, SPC).
• Demonstrated success driving QMS improvements and leading audits.
• Strong analytical, problem‑solving, and decision‑making abilities.
• Excellent communication skills with ability to interface directly with customers and regulatory auditors.
• Proficiency in Microsoft Office applications; experience with ERP/QMS software preferred.

Preferred Qualifications

• Experience in printing, adhesive converting, or flexible materials manufacturing.
• Knowledge of medical device regulatory requirements including 21 CFR 820.
• Experience with PPAP, process validation, and capability analysis.
• Familiarity with supplier quality management and external auditing.
• Strong leadership and team‑building capability
• High attention to detail and documentation accuracy
• Ability to work in a fast‑paced, customer‑driven environment
• Excellent organizational and project management skills
• Professional demeanor and strong customer‑facing communication skills

Physical Requirements & Work Environment

• Ability to sit, stand, walk, and occasionally lift up to 25 pounds.
• Regular exposure to converting and printing equipment environments.