Director, Quality; Buffalo Campus

Position: Director, Quality (Buffalo Campus)
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

Integer is a global provider of innovative technologies and manufacturing solutions to Medical Device OEM’s (original equipment manufacturers) to enhance the lives of patients worldwide.  We are guided by our Values Customers, Innovation, Collaboration, Inclusion, Candor, and Integrity.
** What you’ll do in this role:
** Provide energetic and strategic quality leadership to the manufacturing site(s) assigned to:
* Ensure sites meet customer requirements while maintaining. Compliance with applicable quality and regulatory standards, policies and procedures; and adhere to Integer Values and all safety, environmental, security requirements and regulations.
* Elevate the impact of the local QMS within the overarching Integer QMS.  Lead the execution of quality initiatives to promote and reinforce a culture of quality, customer experience, and innovation.
* Influence and drive change management to design quality into product and process through robust characterization and capability activity, to increase the velocity of improvement.
* Serve as the management representative accountable for the full local QMS.
* Build and lead a high-performing Quality team, fostering company pride.
* Develop a proactive site approach to the customer experience fostering trust, while also serving as a principal liaison for customer quality escalations.
* Review and approve key quality records including but not limited to engineering change requests, customer change notices, nonconformance reports, engineering reports, CAPAs, etc.

You are accountable for correcting and preventing quality related gaps in existing processes and driving process improvements required to enable the organization to execute at a more accurate and efficient level.
*** Build & develop teams:
**** Create and sustain an environment for developing talent from initial onboarding, through individual development planning, and organizational succession planning.  Model the way by coaching team members.  ·
* Advocate effectively for your team, proactively build the team “brand” and embed an ‘I own Quality’ mindset.  ·
* Establish clear objectives, communication rhythms, and an empowered collaborative, inclusive, and accountable culture based on mutual trust.
*** Customer Experience and

Innovation:
**** Serve as the primary quality customer interface, ensuring transparent, timely and responsive communication.
* Improve customer-facing metrics (e.g. Complaint metrics) and prevent recurrence through effective CAPA.
* Champion built-in quality, experiment-and-learn approaches, and data-driven improvements that accelerate safe, reliable new product introductions and product/process changes.
* Encourage, leverage and adopt technology to improve speed, control and visibility in the quality system.
*** Design Assurance, NPI and Design Transfer:
**** Provide design assurance leadership for new products, line extensions, and other customer driven product development.
* Enable a “quality by design” mindset; comply with company’s Product Development Process.
* Partner with R&D and Advanced Manufacturing Engineering to ensure robust design transfer with acceptable process capability and 1st pass yields for production.
*** Manufacturing Support:
**** Align with Plant leadership on prioritized projects, ensuring completion and proactive quality support.
* Ensure plant operates with robust controls for nonconformance and supplier quality processes, including but not limited to containment, bounding, root cause analysis, corrective/preventive actions, and effectiveness checks.  When needed, lead cross site quality resolution.
* Partner with Engineering to…