Quality Manager

MUELLER SPORTS MEDICINE INC•Town of Prairie du Sac, WI

17d•Onsite

About The Position

POSITION OVERVIEW: Oversees material quality control and is responsible for the Quality Management System (QMS) at Mueller Sports Medicine, Inc. (MSM). POSITION FUNCTIONS Percentage Position Functions 20% Leadership and Management 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. 60% Quality Management System (QMS) 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. 10% Cross Functional Cooperation 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. 10% Audits 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). NA Other duties as assigned to meet the needs of the organization. Position Functions for this position consist of all items listed under any category that make up 5% or more of the position duties. This position description is subject to change without notice.

Requirements

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.
Responsible to appropriately protect the confidentiality, security, and integrity of the organization’s systems and data as well as client data.

Nice To Haves

ISO 13485 lead auditor certification is preferred.
ASQ certification, RAPS certification and process audit experience preferred.

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.
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.