Senior Director, Global Design Assurance, Regulatory & Clinical 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

Accountabilities & Responsibilities:

• Adheres 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.
• Manage all aspects of the quality and regulatory system across the enterprise, driving to a harmonized system based on best practices
• Standardize all quality metrics, assuring alignment with underlying procedural elements and driving all aspects of data integrity, including aligning with IT on data collection systems and infrastructure.
• Lead the specification, selection, validation and implementation of an electronic quality management system (EQMS)
• Lead all remediation activities including systematic identification, risk-based prioritization and corrective action. Play lead role in all FDA and other government agency audits and responses to all 483's and major/critical findings.
• Collaborate with all functional groups and QA/RA at all levels of the enterprise to drive a culture of quality by conceiving and implementing specific actions, messages and behaviors that support such a culture.
• Maintain all necessary FDA plant registrations and ISO certifications across all sites, evolving as required based on changes across the enterprise.
• Primary responsibility for all quality systems and quality awareness training.
• Responsible for defining and executing/ providing oversight for all post market surveillance & clinical affairs activities.
• Standardize all enterprise procedures and controls related to environmental monitoring and sterilization in accordance with industry, customer and Integer requirements.
• Responsible for all aspects of Regulatory, Design Assurance & Regulatory Affairs, including but not limited to product registrations, regulatory strategy and remediation, working closely with the Commercial Team, R&D and the Product Group Quality Leaders.
• In collaboration with executive management, develop strategic and tactical plans for national and international regulatory and quality management systems. Regulatory planning includes new product submissions, product registrations, post market surveillance, import and export regulation, safety testing, and national and international requirements.
• Document, implement and continuously improve company quality systems, product reliability, and regulatory processes and activities.
• Ensure proper and timely preparation of national and international submissions in accordance with Company goals and responsible for the associated follow up and reporting activities.
• Responsible for assuring the company is in compliance with all local, county, state and Federal agency regulatory requirements for medical device manufacturers.
• Responsible for management of the internal quality audit system. Interface with FDA other regulatory agencies regarding audit site visits for products manufactured and sold in the United States and abroad.
• Drives and leads activities to streamline processes in Quality consistent with Integer Business Systems. Responsible for driving results against objectives identified for Regulatory Affairs, and Quality Assurance.
• Supports regulatory compliance growth opportunities including strategic and tactical planning that may arise beyond our medical device business, based upon anticipated business growth and strategic initiatives.
• Interviews, hires, and establishes training plans for direct reports. Provides leadership to the supervisory staff regarding development of individuals' goals and mentoring of the group.
• Able to systematically identify and resolve complex problems with an analytical data driven approach and creative thinking.
• Performs other duties as required.

Education & Experience:

• Minimum Education: Bachelor's in Engineering or a technical discipline. Master's degree preferred.
• Minimum Experience: 12+ years of experience in Quality Assurance/ Regulatory in a medical device development and manufacturing environment. Minimum of 10 years of management experience in a medical device development and manufacturing environment with multi-site responsibility

Knowledge & Skills:

• Special Skills: ASQ Certified Quality Manager, Engineer or Six Sigma Black Belt a plus

• Specialized Knowledge:
  • Establish and maintain networks, influence in a matrixed organization, and communicate in a clearly and highly professional manner
  • Demonstrated ability to establish, communicate, and implement long-term strategic and operational goals.
  • Extensive experience with advanced statistical methods: SPC, DOE, ANOVA and others.
  • Extensive experience with product development, design verification, validation, risk management.
  • Effectively manage a large workflow and multiple projects at one time.
  • Strong ability for reasoning and logical deduction and to transfer between abstract and concrete concepts.
  • Expertise in structured problem solving. Able to solve complex problems that require creativity.
  • Experience with improvement tools preferred: six sigma, lean manufacturing, and theory of constraints.
  • .Experience building and leading high performing teams, located in different geographies.
  • Proven ability to lead cross-functional teams in problem solving and to successful outcomes.

In-depth Medical Device Quality Management System knowledge and experience

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