Quality Manager

Job Title: Quality Manager
Department: Quality
FLSA Status: Exempt
Reports To: CEO, North America
Location: Menomonee Falls, WI (On-site)
Schedule: Monday – Friday, 8:00 AM – 4:30 PM

Position Summary

The Quality Manager is responsible for leading the Quality Management System (QMS) and ensuring all products, materials, and processes meet ISO 13485 requirements, customer specifications, regulatory standards, and internal quality expectations. This role drives continuous improvement, oversees quality assurance activities, and provides technical leadership across 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, and operational effectiveness
• Oversee metrology, training, document control, corrective action processes, change control, and quality record retention
• Prepare for and lead internal, supplier, and customer/notified body audits
• Establish, monitor, and communicate QMS metrics, KPIs, and quality objectives

Quality Assurance & Regulatory Compliance

• Ensure production, inspection, and documentation activities comply with ISO 13485, customer, and regulatory requirements
• Manage nonconforming product processes including containment, disposition, root cause analysis, and CAPA
• Lead risk management activities using FMEA, control plans, and validation methodologies
• Support equipment qualification, process validation, and ongoing process monitoring

Continuous Improvement & Process Effectiveness

• Develop and implement quality improvement initiatives to reduce waste, improve product quality, and improve product consistency
• Partner with engineering and operations to enhance converting, slitting, printing, and laminating processes
• Drive reduction of scrap, variability, customer complaints, and internal defects
• Utilize data analysis and statistical methods to identify and implement improvements

Supplier Quality Management

• Evaluate, approve, and monitor suppliers of materials and outsourced services
• Conduct supplier audits and lead supplier performance improvement efforts
• Establish quality expectations and ensure incoming materials meet specifications

Customer Interaction & Technical Support

• Serve as the primary quality contact for customers, supporting audits, regulatory inquiries, and complaint investigations
• Lead preparation and submission of PPAP, FAI, and qualification documentation
• Communicate quality performance, improvements, and issue resolution effectively

Leadership & Team Development

• Supervise, train, and develop quality personnel
• Promote a culture of accountability, continuous improvement, and quality ownership
• Ensure consistent application of quality policies and procedures across the organization

Required Qualifications

• Bachelor’s degree preferred; equivalent experience considered
• 5 years of quality experience in a regulated manufacturing environment
• Strong working knowledge of ISO 13485 within a supplier or manufacturing environment
• Experience with risk-based quality tools (FMEA, control plans, validation, SPC)
• Proven ability to lead audits and drive QMS improvements
• Strong analytical, problem-solving, and decision-making skills
• Effective communication skills with customer and auditor interaction experience
• Proficiency in Microsoft Office; experience with ERP/QMS systems preferred

Preferred Qualifications

• Experience in adhesive converting, printing, or flexible materials manufacturing
• Knowledge of medical device regulations, including 21 CFR Part 820
• Experience with PPAP, process validation, and capability analysis
• Background in supplier quality management and external auditing

Key Competencies

• Leadership and team development
• Continuous improvement mindset
• Attention to detail and documentation accuracy
• Strong organizational and project management skills
• Ability to operate in a fast-paced, customer-driven environment
• Professional and effective communication skills

Physical Requirements & Work Environment

• Ability to sit, stand, and walk for extended periods
• Ability to lift up to 25 pounds occasionally
• Exposure to manufacturing environments, including converting and printing equipment
• Use of required personal protective equipment (PPE)