This role provides energetic and strategic quality leadership to assigned manufacturing sites, ensuring compliance with customer requirements and regulatory standards. The Director will elevate the impact of the local Quality Management System (QMS) within the overarching Integer QMS and lead quality initiatives to foster a culture of quality, customer experience, and innovation. The position involves driving change management to design quality into products and processes and serving as the management representative accountable for the full local QMS.
Responsibilities
Ensure sites meet customer requirements while maintaining compliance with applicable quality and regulatory standards, policies, and procedures
Adhere to Integer Values and all safety, environmental, and 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 engineering change requests, customer change notices, nonconformance reports, engineering reports, CAPAs, etc.
Correct and prevent quality-related gaps in existing processes and drive process improvements required to enable the organization to execute at a more accurate and efficient level
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
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
Millions of jobs, with real people getting hired every day
200,000+
New jobs added daily
7,000,000+
Verified job listings
1,000,000+
Tailored applications submitted
Provide design assurance leadership for new products, line extensions, and other customer-driven product development
Enable a “quality by design” mindset; comply with the 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
Align with Plant leadership on prioritized projects, ensuring completion and proactive quality support
Ensure the plant operates with robust controls for nonconformance and supplier quality processes, including containment, bounding, root cause analysis, corrective/preventive actions, and effectiveness checks
Lead cross-site quality resolution when needed
Partner with Engineering to support tooling, equipment, and process improvements
Support simplification and lean (5S) principles across the sites
Manage budget and strategic plans
Develop business case justifications for additional resources and investment when appropriate
Embrace the Manufacturing Excellence culture based on the Integer Production System and its five focus areas:
Strategy Alignment through 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 processes and products in compliance with all customer 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 at all levels of the organization, promoted through collaborative problem solving, behavior-based safety programs, and improvement idea and systems
Systems & Process Optimization through adoption of principles of built-in quality, optimized scheduling & material system designs, work cell design, and total productive maintenance
Requirements
Bachelor’s degree in a quality engineering or related field
10+ years of experience, including 6+ years in management in a Medical Device or other regulated manufacturing environment
Expertise in 21CFR820, ISO13485, ISO9001, EU MDR, Good Manufacturing Practices, auditing, design controls, and statistical concepts including Design of Experiments, Capability Studies, Validations, etc.
Strong critical thinking and problem-solving skills with excellent written and verbal communication skills
High degree of Emotional Intelligence and can share examples of developing talent
Limited travel (less than 25%)
Current passport and ability to secure appropriate visas, as required, for travel to international locations
Nice to have:
Master’s degree
Certifications such as ASQ Quality Manager/Engineer or Six Sigma Black Belt
Important Details
Travel: less than 25%
About the Company
Integer is a global provider of innovative technologies and manufacturing solutions to Medical Device OEMs (original equipment manufacturers) to enhance the lives of patients worldwide. The company is guided by its values: Customers, Innovation, Collaboration, Inclusion, Candor, and Integrity.
