Quality Manager

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:

• 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.
• Conduct supplier audits and lead supplier improvement initiatives.
• Establish clear quality expectations and ensure incoming materials meet specifications.
• 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.
• 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

• Bachelor’s degree preferred; equivalent experience considered.
• 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.
• Experience in printing, adhesive, or flexible materials manufacturing (preferred)
• Knowledge of medical device regulatory requirements including 21 CFR 820. (preferred)
• Experience with PPAP, process validation, and capability analysis. (preferred)
• Familiarity with supplier quality management and external auditing. (preferred)