EVP, Global Quality & Regulatory Affairs

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

Job Summary:

The Executive Vice President of Quality Assurance & Regulatory Affairs is responsible to establish focus and provide for the administration of the organization's quality improvement efforts. In addition, the incumbent will consult with their peers on the attitudes and practices of quality throughout the organization to develop an environment of continual improvement in every aspect of the company's products and services. The Executive Vice President of Quality Assurance & Regulatory Affairs will act as a champion for quality and will be the Quality Representative on the Senior Management team. Responsible for the development and implementation of programs designed to validate the effectiveness and integrity of all manufacturing processes and systems. This will be achieved through the deployment and maintenance of Quality Systems in all aspects of the company's operations. In addition, the Executive Vice President of Quality Assurance & Regulatory Affairs will ensure the highest standard of customer satisfaction by delivering the right product to meet or exceed customer expectations. The position is responsible for all activities within the Quality Function, including Quality Engineering, Quality Control, Receiving, Inspection as well as Document Control and Compliance. The position is also responsible for the Environmental Health Safety Security (EHSS) Corporate Function.

Accountabilities & Responsibilities:

• Adheres to Integer's 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.
• Directs, controls and staffs the Quality department to ensure support for execution of Quality systems meets requirements. Continually reviews requirements related to new processes, new products introduction and changes in technology, customer needs and safety and environmental regulations.
• Establishes policies and procedures based on ISO 13485 and/or FDA GMP standards for all companywide processes.
  • Provides training and certification for all employees and processes.
  • Maintains company's conformance to the standards and an internal audit system.
  • Audits outsourcing partners for compliance.
• Establishes Quality Control plans for all product lines in manufacturing and provides training, inspection and verification tools and schedules verification audits to ensure product assembly, testing and processes conform to the Quality Control plans and instructions.
• Facilitates new product ramps and ensures all first articles (including labeling and packaging) and performance requirements meet specifications and design requirements.
• Establishes a supplier management program with the materials management team to track Quality of products and on-time-delivery performance of different suppliers. Reviews such findings periodically with the suppliers to communicate their performances and discuss corrective measures, as necessary.
• Establishes a receiving inspection system for incoming material. Identifies tools and inspection equipment required and establishes inspection guidelines for each type of materials and components. Develop metrics for Quality and vendor analysis.
• Establishes a central Quality records database and ensures integrity of the data and data accessibility.
• Establishes a comprehensive traceability system for product assembly process, supplier materials, components and finished goods shipped to customers.
• Participates in product and process improvement projects with the design, manufacturing engineering, test engineering, sales and marketing and production teams.
• Establishes a failure analysis system with adequate technical and lab staff to support:
  • Troubleshooting
  • Root cause analysis
  • Incoming materials failure analysis
• Failure analysis on customer returns.
  • Ensures reporting and corrective actions are taken in a timely manner.
• Directs and maintains a qualification and environmental lab that supports product reliability and life testing, new product qualification and Quality verification for customers. Such efforts shall be coordinated with the Quality control group in the company's headquarter in the United States and other design centers, including Malaysia, Taiwan, etc.
• Establishes systems and procedures for containment of non-conforming materials and products throughout the company. Executes a disposition system with departments involved.
• Establishes performance goals for product Quality and yields and reviews regularly for cause of deviations and provides guidelines and support for improvements with project-based approaches such as design of experiments, statistical tools, and capability studies.
• Establishes comprehensive tools, equipment and inspection systems calibration programs and ensures all are compliant.

Education & Experience:

• Minimum Education:

Bachelor's Degree required and acceptable fields of study are Operations Management, Engineering or similar technical discipline.

• Minimum Experience:
  • 8-10 years senior management experience in a manufacturing environment.
  • Experience in healthcare or regulated industry with multiple plant leadership preferred.
  • Multiple plant experience on an international scale.
  • Must be familiar and understand recognized regulatory standards such as (but not limited to) 21-CFR- 820, ISO13485-(EN) ISO 13485, ISO 14971, CMDR and MDD.
  • Proven track record of managing technical employees, building high-performance manufacturing organization and delivering high quality products on time and on budget.
  • Experienced in developing and sustaining products in compliance with ISO standards and in an FDA regulated environment. Knowledgeable about the highly regulated nature of this business and comfortable functioning within such an environment.
  • Excellent communication, public presentation and meeting management skills.

Knowledge & Skills:

• Special Skills:
  • Developing talent, interpersonal relations and influence, integrity, communication, customer focus.
  • Open to extensive travel and relocation as required. Ability to travel globally.
  • Ability to analyze, understand and effectively communicate deep technical material.
  • Ability to work in a demanding user environment.
  • Excellent communication, public presentation and meeting management skills
  • Possesses a high sense of urgency.
  • Comfortable in a very direct and candid environment focused on results.
  • Ability to accurately assess and set priorities to drive operational improvement.
  • Passion for building a talented organization and specific track record of recruiting and developing highly capable operations talent.
  • Kaizen and Lean manufacturing experience.

U.S. Applicants: EOE/AA Disability/Veteran