Quality Manager

Quality Manager The Quality Manager is responsible for leading quality improvement for a manufacturing or service facility/function. This position leads the implementation and maintenance of state-of-the‑art quality practices for associated product and service lines. The Quality Manager assumes overall responsibility in ensuring that the site maintains operational and quality systems in a state of compliance to domestic and international standards. The role is responsible for the organization, documentation and maintenance of the quality system to be compliant with, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and CFR Part 820/211, EU MDR and other applicable standards. This role leads the local site efforts focused on product/service quality improvement, supplier quality, process quality, new product/service development quality and quality system compliance. The Quality Manager serves as the Management Representative for the assigned site(s) and is responsible for ensuring the quality system meets all applicable regulatory standards. Lead the organization's Quality staff to ensure compliance to the overall Quality Management System and drive continuous improvement. Lead the organization's Quality staff to ensure alignment to manufacturing and servicing operations, support Lean efforts and drive quality improvement for products and services. Work closely with site senior management to provide strategic direction and development of the organization's quality strategies and tactics. Provide quality viewpoints and opinions on future product and service development. Provide coaching, mentoring and leadership to the Quality staff. Serve as the site's Management Representative and lead the organization's Management Review process. Ensure compliance with appropriate domestic regulatory and international standards and requirements. Lead the organization's continuous improvement process, including data analysis, improvement projects and process capability to improve key metrics as measured by the product/service quality dashboard. Lead and implement effective production and process controls. Manage the complaint handling processes to ensure customer responsiveness and product and process improvements. Ensure compliance with the New Product Development process and assurance that the Product Requirements Document includes key quality performance metrics. Assess new designs for manufacturability, testability and reliability to ensure the Quality risks and deliverables of the New Product Development process meet the required application reliability and design intent. Determine supplier qualification risks based upon criticality of component and supplier process capability. The position requires a level of authority to conduct and direct required activities such as quality planning, personnel management and regulatory compliance. This individual has autonomy to perform the duties of Person Responsible for Regulatory Compliance (PRRC) on behalf of HuFriedyGroup legal manufacturing entities under the EU MDR. This individual shall suffer no disadvantage within the organization in relation to proper fulfilment of his or her duties in lieu of article 15 of the EU MDR. Perform other duties as assigned. Functional Knowledge, Skills & Abilities: 8-10 years' experience in Manufacturing/Quality Engineering and/or Quality Systems. 8-10 years' experience working in an ISO certified environment required. 8-10 years' experience working In a Quality leadership role. Bachelor's degree required Experience with ASQ, QSR or familiarity with QSR/GMP regulations. Medical device or other regulated industries preferred. Excellent problem-solving skills Focus on identification of potential issues and continuous improvement. Experience working on cross-functional teams and on own initiative. Demonstrated excellent organizational, oral and written communications skills. Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint. Experience with statistical analysis software and Visio preferred. Benefits: Healthcare, Vision, Dental, 401K Match, PTO, Company Holidays Equal Employment Opportunity & Accessibility Statement HuFriedyGroup is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We prohibit discrimination and harassment of any kind based on race, color, religion, age, gender, national origin, disability status, genetics, veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. #J-18808-Ljbffr