Director Of Quality Assurance And Regulatory Affairs

Milliken & Company is a global manufacturing leader whose focus on materials science delivers tomorrow’s breakthroughs today. From industry-leading molecules to sustainable innovations, Milliken creates products that enhance people’s lives and deliver solutions for its customers and communities. Drawing on thousands of patents and a portfolio with applications across the textile, flooring, chemical and healthcare businesses, the company harnesses a shared sense of integrity and excellence to positively impact the world for generations. Discover more about Milliken’s curious minds and inspired solutions at Milliken.com and on Facebook, Instagram, LinkedIn and Twitter.

POSITION TITLE / LOCATION

DIRECTOR OF QUALITY ASSURANCE AND REGULATORY AFFAIRS /DIVISION

JOB CLASSIFICATION

DIRECTOR OF QUALITY ASSURANCE AND REGULATORY AFFAIRS

POSITION REPORTS TO:

Healthcare Division President

POSITION OVERVIEW

Job Description:  Individual in this position will be part of a dynamic team with a proven track record of inventing, developing, and commercializing FDA registered medical devices.  In this role the individual will interact with all functional areas of Milliken Healthcare.  The Director ofRegulatory Affairs and Quality Assurance provides strategic leadership and focus for the Quality Management System. This position leads the quality teams for Milliken & Company- Healthcare Division in establishing and continuously improving critical aspects of products and quality system to achieve business objectives.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES FOR QUALITY SYSTEMS

•   Oversee division wide team to develop, implement, communicate, and maintain effectiveness of a quality system that follows FDA QSR and ISO 13485 standards.
•   Supports cross functional teams during new product development, process development and qualification, and acquisition activities.
•  Establishes and administers division Quality Management System
• Ensures appropriate communication processes within the organization regarding the effectiveness of the quality management system.
• Oversee division quality inspection and product release programs for a) incoming raw materials, b) in-process materials, c) components and d) finished goods.
• Set Quality Assurance objectives for the review and approval of Top Management and ensure that targets are achieved.
• Oversee team that establishes and maintains appropriate controls and documentation procedures.
• Provide quality leadership for product development activities to ensure proper Quality Assurance and control plans can be implemented prior to beginning manufacturing.
• Ensure an effective supplier Quality Assurance system while ensuring supplier corrective actions are timely and effective.
• Ensure quality agreements are in place and acts as signatory for all quality agreements between Milliken Healthcare Division and suppliers/ customers.
• Provide support for new inspection, measurement and testing systems for quality monitoring and improvement.
• Provide leadership and support for investigations of Quality issues.
• Recruits, develops, and manages the Quality Assurance department.
• Develop and maintain an effective quality systems and Regulatory Affairs training program for all appropriate business associates.
• Manage all audit activities including internal, external, supplier, and FDA audits.
• Develops budget for the Quality Assurance department.
• Conduct Management Reviews on a regular basis.
• As a key and senior member of the Leadership team, the Director is expected to participate in operational and strategic discussions that impact the entire organization.
• Develop and implement appropriate regulatory systems to ensure required communication with regulatory bodies are maintained (e.g., adverse event reports, post-market feedback, recalls, and labeling changes).
• Responsible for overseeing the review of data and release of all products and ensure that the product characteristics meet appropriate quality specifications and regulations/guidelines.
• Oversee review and approval of procedures, production records and specifications.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES FOR REGULATORY AFFAIRS

• Act as company management representative for FDA and other agencies
• Liaison with ISO 13485 registrar to ensure activities are completed to maintain ISO 13485 registration.
• Understand current global regulations affecting medical devices with particular focus on the United States, Canada, and EU.
• Develop strategies, draft responses, and/or review responses and documents intended for submission to regulatory agencies to ensure compliance with regulatory requirements and / or gain clearance for commercial sales.
• Interact with regulatory agencies as directed while documenting contact as required to gain product clearance.
• Provide business-sensitive regulatory advice.
• Provide regulatory expertise and support for pre-clinical, clinical, and commercial areas for investigational and marketed products.
• Manage projects utilizing outside consultants including seeking clearance for commercial sales in other countries.

REQUIREMENTS & QUALIFICATIONS

• BS/BA, Masters, or PhD
• Minimum of 15 years of experience in Quality and/or manufacturing support, including at least 10 years of supervisory experience.
• Experience with quality management in sourcing / third party manufacturing.
• Experience with electronic documentation management systems.
• Extensive internal and external auditing experience.
• Comprehensive knowledge of current industry manufacturing and quality best practices and the ability to correctly interpret regulations and standards.
• Working knowledge in quality sciences, statistics, and computer-based operations.

Milliken is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to actual or perceived race, color, creed, religion, sex or gender (including pregnancy, childbirth or related medical condition, including but not limited to lactation), sexual orientation, gender identity or gender expression (including transgender status), ancestry, national origin, citizenship, age physical or mental disability, genetic information, marital status, veteran or military status or any other characteristic protected by applicable law.