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Senior Manager, Quality

External
integer logoInteger · Trenton, GA
Full-timeOn-site1w ago
ComplianceLeadership
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About the role

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do. Customer We focus on our customers' success Innovation We create better solutions Collaboration We create success together Inclusion We always interact with others respectfully Candor We are open and honest with one another Integrity We do the right things and do things right Who are we? Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEM's (original equipment manufacturers) to enhance the lives of patients worldwide. Working at Integer means you are part of a team passionately pursuing excellence in all that we do and always reaching for the next great achievement. What you'll do in this role: The primary purpose of this role is to lead the manufacturing site or sites assigned to ensure they meet and continue to meet customer requirements while remaining in compliance with the associated quality management system policies and procedures. You will provide leadership for a team of Quality function professionals, including any combination of Quality Supervisors, Quality Engineers, and individual performers. As a manager, you define and champion the evolution of the core elements of the local Quality System to standardize with the overarching Integer QMS. You are responsible for the entirety of the local quality management system which includes but is not limited to Management Review, CAPA, Complaint Handling, Document Change Management, Design Control, Production control, internal and Customer nonconformance management, Supplier Quality Audits, and Internal QMS Audits. This role may also serve as the management representative. You adhere to company policies and procedures and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements as required within your location. You are accountable for preventing and correcting quality related gaps in existing processes and systems and driving process improvements required to enable the organization to execute at a more accurate and efficient level. Build & develop teams: You lead, coach, and develop a team of quality professionals in support of one or more product lines or process areas within a design/manufacturing site or a business category. As an element of our belief that we all Own Quality, you establish a culture of quality amongst your team and across the site and/or business and establish the expectation for compliance to the established Quality Management System. You establish objectives for your team members, ensure effective communications throughout the team, and provide active support for each team member to aspire to accomplish the Individual Development Plans that each one establishes as a means of professional skills development. Your leadership style encourages teamwork, cross functional consensus building and ensures accountability within your team and across the interactions your team members have with others inside and outside Integer. You promote a diverse and inclusive work environment where your team feels supported and openly communicates opportunities and issues knowing they share a feeling of mutual trust. Manufacturing Support: You serve as a key interface, directly and regularly, with internal and external customers. You are a key contributor to the site or business Hoshin plan ensuring that the strategies for driving the Quality initiatives consistent with the journey to differentiated quality are specified and prioritized. You are responsible for ensuring the completion of projects as assigned to you. Proactively, you manage the risk(s) associated with quality concerns. You provide input into and manage your department budget, department strategic plans and quality plans. You are the functional level support to your team ensuring that rigorous root cause analyses have been initiated and/or completed. Based on your assessment of a specific situation, you may recommend and coordinate cross functional and/or organizational support to resolve an issue. You promote a diverse and inclusive work environment where your team feels supported and openly communicates opportunities and issues knowing they share a feeling of mutual trust. Support Site Quality Activities: You exemplify Quality- "I own Quality." You are a standard bearer for Quality in everything we do at Integer, contributing to the successful attainment of our quality Key Performance Indicators and journey to differentiated quality. You champion the development of and deployment of the systems and tools to drive innovation and continuous improvement within the


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