Quality Systems Manager

Job description

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 and a provider of high-end niche batteries for specialized applications in the energy, military, and environmental markets. We are guided by our six Values, including focus on Customers, Innovation, Collaboration, Inclusion, Candor, and Integrity. 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 provide leadership for a team of Quality professionals, with responsibilities for establishing and maintaining the Quality Management System (QMS) and leading assessments for a manufacturing site and/or business category. As a manager, you define and champion the evolution of the core elements of the local Quality System to harmonize with the overarching Integer QMS. In addition, you are accountable for correcting potential gaps in existing processes and systems and driving process improvements required to enable the organization to execute at a more accurate and efficient level. 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. Build & develop teams: You lead, coach, and develop a team of quality professionals in support of the Integer Quality System and assessing systems within a 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 organization 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 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. Support Site & Quality Systems 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 are responsible for the scheduling and implementation of the Integer PCAS process. You will perform PCAS assessments on individual sites, provide a detailed report and support the site to root cause and implementation of corrective actions. You champion the development of and deployment of the systems and tools to drive innovation and continuous improvement within the Quality Management System. Proactively, you manage the risk(s) associated with quality concerns. You manage the department budget, department strategic plans and quality plans. You may perform other duties as needed and as directed by your manager. Provide support of Integer’s Strategic Imperatives: You embrace the Manufacturing Excellence culture based on the Integer Production System and its five focus areas:Strategy Alignment by attending quality planning meetings at Enterprise Quality level and through all-hands communication meetings. Leadership of Sustained Change by identifying opportunities to continuously improve our processes and ensuring implementation of such changes comply with contractual obligations and regulatory requirements. Standardization through generation and the adoption of Integer Quality policies, procedures and systems. Associate Engagement promoted through the collaborative problem solving, that includes working with associates at all levels of the organization, and through participation in behavior-based safety programs, and improvement idea and suggestion systems. Systems Optimization through introduction of standardized quality management systems, programs, and software tools. How you will be measured: The specific measures listed below may be subject to change and are not intended to be an all-inclusive list. Safety — Safety is our highest priority; you will be an active supporter of the Integer Environmental, Health & Safety programs. Delivery — You will have defined Goals and Objectives specifying key projects and expected milestones to achieve. Quality – Achievement of associated Quality System KPI’s Cost Improvement — Cumulative incremental savings realized as a result of your accomplishments and collaboration, particularly in support of continuous improvements. Cost Controls — Adherence to budgets Engagement – Promote Associate engagement and support each Associate’s Individual Development Plan; coach direct reports in support of their career plans and professional development and represent their interests in Talent and Succession Planning processes. What sets you apart: Minimum educationYou have earned, as a minimum, a bachelor’s degree in an engineering or related technical field. A master’s degree is preferred. Minimum experience:You have at least 8 years of experience in a manufacturing environment in which ISO standards’ governance and/or regulatory compliance were expected. You have prior supervisory or leadership experience. Specialized knowledge:You possess the technical competence using and deploying such concepts as Root Cause Analysis, Problem Solving Skills, statistical analysis, and capability assessments. You have specialized knowledge in the performance of this role e.g., EU MDR, ISO 13485, ISO 9001, MDSAP, Good Manufacturing Practices 21CFR820 and Good Documentation Practices along with auditing experience. You have previous experiences applying procedures and concepts within your own discipline as well as basic knowledge of other disciplines. You demonstrate the aptitude and interest in learning the details about new products, the processes for manufacturing such products, establishing the controls and governance procedures for maintaining consistency, and adhering to customers’ requirements. Specialized skills:You articulate a personal strategy for what it means to lead, to take leadership actions, to create and share a strategic vision, and to align a team to achieve that vision. You have a tool kit of leadership skills aligned with Integer’s values. You enjoy a fast-paced and complex work environment in which you must make decisions in a timely manner. You maintain a calm demeanor that transcends the high energy, constantly changing production environment and customer landscape. You possess a positive, can-do attitude with an underlying belief that failure is not an option. U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.