Director, Quality Assurance and Regulatory Affairs
Integer Holdings Corporation (ITGR) is one of the largest medical device outsource (MDO) manufacturers in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and portable medical markets. The company provides innovative, high-quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company's brands include Greatbatch Medical, Lake Region Medical and Electrochem. Additional information is available at www.integer.net.
The Director, Quality Assurance and Regulatory Affairs serves as a trusted advisor and key partner to site Quality and other plant leaders on all aspects of Quality. This position leads the execution of strategic quality initiatives and promotes and reinforces a culture of quality within respective plants, and is the Principal Liaison for contact between Integer and customers on all critical site matters related to quality requirements. The incumbent is responsible for providing the regular Product Category Quality Performance Status report outs to the Product Category Senior Quality Leader for the product category sites for all aspects of quality systems, regulatory affairs and compliance in accordance with all industry, U.S. and foreign regulatory standards, customer and Integer standards.
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.
Serves as Change Champion for Product Category and respective sites to engage Associates in translating the Quality and Regulatory Vision into reality.
Recognized as principal Quality contact and advocate to customers in assigned Product Category and represents Quality in Product Category customer business reviews, executive partnership meetings and customer escalation events, establishing and maintaining customer communications and credibility as the Integer champion.
Directs the management of all business-impacting changes across the sites. Leads and is responsible for success of activities to streamline Quality processes to ensure consistency with Integer Business Systems within the Product Category and alignment with global owners of such Quality System processes.
Leads consolidation and communication of monthly report outs on key customer interactions, including complaint/post market status, Quality agreements, regulatory request status and product submission/certification status.
Plans, executes, and manages Quality related project activities across the Product Category sites with the site Quality managers.
Interfaces directly and regularly with internal and external customers. Responsible for projects that are of the highest priority with high visibility by customers. Proactively manages the risk associated with Quality concerns.
Communicates regularly with executive management and administration regarding the management of current projects; obtains executive management guidance and approval as required
Reviews and provides guidance on documentation to ensure a high degree of accuracy, completeness, and effectiveness.
Drives consistent use of QA/RA KPIs across responsible plants to ensure measured performance improvements based on root cause analysis and defining/ deploying appropriate preventive and corrective actions.
Reviews Quality Agreements for site related agreements in alignment with Global QS and Legal review.
Responsible for all remediation activities including systematic identification, risk-based prioritization and corrective action.
Analyzes internal site assessment and audit trends to develop best practice processes.
Performs other duties as required.
Education & Experience:
Minimum Education: Bachelor's in Science, 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:
Able to partner effectively with internal and external partners in a proactive, positive and constructive manner.
Able to manage multiple projects and timelines, and accommodate multiple priorities in a fast paced and changing environment.
Able to systematically identify and resolve complex problems with an analytical data driven approach and creative thinking.
Organized and detail oriented, demonstrates a high level of commitment and drive for excellence, and generates enthusiasm.
Strong collaboration, communication and leadership skills to effectively and clearly coordinate across Product Category sites with the site QM.
Experience and expertise applying change management principles and practices to drive successful enterprise transformation
Demonstrated influencing skills with all levels of key stakeholders during times of transformation and other situations. Specialized Knowledge:
Demonstrated ability to establish, communicate, and implement long-term strategic and operational goals.
Demonstrated knowledge of U.S and EU regulatory requirements and standards as it relates to pre-market approval, interactions with regulatory bodies, post-market surveillance, risk management and oversight of corrections and removals.
Experience with advanced statistical methods: SPC, DOE, ANOVA and others. ASQ of equivalent Certified Quality Engineer, Certified Six Sigma Black Belt or Certified Quality Manager strongly preferred
Experience with product development, design verification, validation, risk management.
Has effectively managed 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.
In-depth Medical Device Quality Management System knowledge and experience
Intermediate to advanced proficiency with MS Office Suite (Word, Excel, PowerPoint, Project, Outlook); Adobe Professional.
Proficiency in reviewing, reading, analyzing, and interpreting general business periodicals, professional journals, technical procedures, and governmental regulations.
Expert in writing reports, business correspondence, and procedure manuals Other:
Travel: The position requires approximately 25% domestic and international travel to all applicable sites.