Mueller Sports Medicine, Inc. · 16 hours ago
Quality Manager
Prairie du Sac, WI
Full-time
Onsite
Senior Level
5+ years expMueller Sports Medicine, Inc. is a company focused on quality management in the sports medicine sector. The Quality Manager is responsible for overseeing the Quality Management System (QMS), leading the quality department, and ensuring compliance with regulatory standards while managing quality inspections and audits.
Health CareMedicalSports
No H1B
U.S. Citizen Only
Responsibilities
Lead all aspects of quality including the QMS
Provides leadership for the quality department. Manages with excellence, utilizes resources efficiently, and develops talent
Develops innovative strategies to enhance performance of associates
Direct strategy and tactics to achieve annual objectives
Produces and monitors an annual budget
Reviews and develops department related company policies
Provide coverage for Regulatory Compliance Manager as needed. This requires cross-training and collaboration between both positions
Maintains, continuously improves, provides corrective/preventive action and training procedures supporting the QMS
Assure that the quality inspections can be carried out, as needed
Properly train associates and cross-training to conduct quality inspections, as necessary
Manage nonconforming (NC) material process including facilitation of the Material Review Board (MRB)
Manage domestic and international sub-contractor quality control systems including 3rd party quality services
Ensure material activities are within guidelines of the Food and Drug Administration including Quality System Regulation (21 CFR 820), current Good Manufacturing Practices (21 CFR 210), EU MDD, EPA and OSHA
Process owner for document change control and records management of device history records, manufacturing batch records and product files
Train new associate’s in quality system procedures and regulatory guidelines
Collaborate with Purchasing, Engineering and Innovation in review and sign-off of product drawings and specifications
Support Purchasing in reviewing product related to sourcing projects, as well as vendor quality performance & tracking program
Work with Engineering and Innovation to ensure quality requirements are met as a design team member. Provide inspection support at various phase gates for MSM’s stage gate process
Support continuous cGMP, ISO and Hazmat training, as needed for associates
Actively participate in Risk Management Team to provide input and feedback regarding risk analysis activities
Lead and manage internal audit process including scheduling, training, and determining effectiveness
Lead/manage FDA (food, drug and medical), ISO 13485, EPA and other external audit events (State, Federal & Local)
Other duties as assigned to meet the needs of the organization
Qualification
Required
Bachelor's degree in quality assurance, engineering or other related field or an equivalent combination of education and experience sufficient to perform the position functions of the job
Five or more years of quality, engineering, innovation or other related experience
Three or more years of progressive leadership and management experience
Ability to understand and comply with Mueller Safety Systems and current regulatory requirements
Exercises judgment within broadly defined practices and policies
Makes sound decisions based on analysis, discussion, experience and judgment
Demonstrated team player with active participation in meetings
Selects, evaluates, and engages team members
Strong planning and project management skills
Strong ability to transition efficiently from working independently to working collaboratively
Anticipates emerging and future trends accurately based on broad knowledge and perspective
Willingness to “roll up your sleeves” to help find new opportunities, be diligent in holding people accountable, and having passion to WIN
Excellent written and verbal communication skills, with ability to communicate at all levels of the organization
Communicate a vision and providing motivation and direction to team members
Develops and maintains interpersonal relationships
Strong organizational and problem-solving skills, attention to detail, and the ability to balance multiple priorities
Advanced use of Microsoft products, including Word, Outlook and Excel, and related industry applications
Creates focus and eliminates roadblocks for team members
Develops and manages a budget
Valid driver's license
Valid United States passport
Preferred
ISO 13485 lead auditor certification is preferred
ASQ Certification, RAPS Certification And Process Audit Experience Preferred
Company
Mueller Sports Medicine, Inc.
Winning starts in your heart, travels to your head, courses through your veins, then pours out of your body. Keeping athletes in the game.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Brett Mueller
CEO
Recent News
Family Features
2025-11-20
2025-06-02
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