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
strategic leadership to 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 serve as a trusted advisor and key
partner on all aspects of Quality to a team of Quality function
professionals, including any combination of Quality Supervisors, Quality
Engineers, and individual performers. You will 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 is also the leader for the site to ensure
compliance to all product and quality system regulations. This role may
also serve as the management representative, Person Responsible for
Regulatory Compliance (PRRC) and other similar roles as required. You
may lead the execution of enterprise quality initiatives and promote and
reinforce a culture of quality across the enterprise, business, and
site. You may also serve as a principal liaison for escalated contacts
between Integer and customers involving quality matters associated with
a product or product line as well as quality management system issues.
You will adhere to Integer Values and all safety, environmental,
security and quality requirements including, but not limited to: Quality
Management Systems (QMS), Safety, Environmental and Security Management
Systems, U.S. Food and Drug Administration (FDA) regulations, company
policies and operating procedures, and other regulatory requirements.
You are accountable for preventing and correcting potential 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: One of your primary
responsibilities will be to lead your direct reports, which include any
combination of Quality Managers, supervisors, quality engineers, and
other quality, regulatory affairs and engineering professionals. As
such, you will champion talent development within the quality
organization by leveraging individual growth and development plans and
organizational succession plans. 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 Qua ity 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. Other duties may be
assigned. Manufacturing Support: You serve as a key interface, directly
and regularly, with internal and external customers, including
regulatory agencies. 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 for which you are assigned. Proactively, you
manage the risk(s) associated with quality concerns. You provide input
to and manage the 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 Quality
Management System. 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 through Site Hoshin Plans, quality planning meetings, as
Quality representative at site Plant Leadership team meetings, and
through site all-hands communication meetings. Leadership of Sustained
Change by identifying opportunities to continuously improve our
processes and products and ensuring implementation of such changes
comply with all customers contractual obligations and regulatory
requirements. Standardization through workplace organization & visual
controls (5S), Manufacturing Standard Work, robust training &
certification programs and the adoption of Quality policies and
procedures that are aligned to and harmonized with the enterprise
(Integer) Quality Management System. 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 & Process Optimization through adoption of principles
of built-in quality, optimized scheduling & material system designs,
work cell design, and total productive maintenance. 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 is our highest
priority; you will be an active supporter of the Integer Environmental,
Health & For full info follow application link. Equal Opportunity
Employer, including Disabi
