The Head of Quality and Regulatory Affairs will oversee the Quality & Regulatory Affairs across all manufacturing sites and design centers. This position will also be a member of the Leadership Team. Functioning in a matrix management environment and managing the Quality and Regulatory Affairs groups across multiple sites, the Head of QRA has responsibility for leading the business strategic quality plan in collaboration with the Leadership Team. The Head of QRA is responsible for all interactions with FDA and other regulatory bodies related to our growing business and ensuring an effective Quality Management System designed to meet appropriate business unit, government, and international standards/regulations for efficacy, safety, quality and compliance for the design, manufacture and service of medical devices, drug delivery, and primary pharmaceutical packaging products. Results are achieved through associates who are committed to a culture of regulatory compliance, high quality, continuous improvement, safety, and customer focus.
Essential Duties and Responsibilities
Provide strategic decision making, leadership, planning and prioritization including agility in effective and efficient use of resources and organizational structure across the segment to meet business and quality/compliance objectives.
Ensure compliance with CFR 210/211, ISO 9001/ISO13485, CFR 820 FDA Quality System Regulations
Be the primary contact during regulatory inspections. He/she will be responsible for managing escalated customer issues and driving continuous improvement activities.
Ensure the functional perspective of quality goals are directly tied to market needs and business goals with an emphasis on agility in execution and driving problem resolution to accelerate the pace of delivering to objectives.
Identify and address gaps related to all aspects of product quality and compliance (e.g., product, quality systems, people), including opportunities for continuous ongoing innovation and improvements.
Assure the absence of significant quality issues and regulatory compliance actions by global government agencies through the design and governance of robust, efficient and consistent Quality Systems, internal and external audit programs, and inspection readiness programs.
Proactively identify and alerts organization of quality issues/complaints in time to resolve potential adverse effects to the customer, company image/reputation and/or the business.
Oversee the development and application of metrics appropriate to the business.
Assure all supplier quality systems are consistent with worldwide quality and regulatory requirements.
Direct the preparation of the department budgets and maintains operating costs within constraints of those budgets.
Build strong relationships with internal and external leaders across the to ensure overall quality and regulatory compliance.
Inspire, motivate and communicate vision to associates, peers, leadership and build consensus toward adoption of and commitment to appropriate standards for quality in support of market needs and business goals.
Determine and develop quality and compliance competencies and skills needed for the on-going success of the business.
Create and sustain the culture of customer focused innovation, efficiency and balanced risk management.
Maintain compliance within a highly regulated environment.
Develop and implement a clear customer centric vision for Respiratory& Quality. Lead, Inspire and Communicate vision to internal and external leaders across the organization.
Support strategic business objectives.
Develop a talent plan to ensure the right capabilities are in place to align with QRA and business objectives. Develop succession plan for all critical positions and ensure development plans are in place for these individuals.
Required Skills and Experience
Experience in Design Assurance, Operations Quality, Risk Management, Regulatory Compliance, and Complaints Handling
Minimum of 10 years of experience in FDA regulated quality management with at least 5 years of senior management experience in an FDA regulated environment.
Experience leading or actively participating in FDA inspections required.
Technical aptitude and background in electromechanical devices preferred.
Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry e.g., ISO, QSR, GMP, GLP, GCP, HIPAA.
Experienced and knowledge in all regulatory compliance aspects of medical devices: pre-market, commercial, post market, and regulatory.
Experience in design assurance/control and operations quality.
Demonstrated expertise in the design, implementation and measurement of quality systems and metrics.
Initiative in innovative approaches to quality and compliance in a fast paced changing business environment.
Excellent written and oral communication and organizational, project management skills.
Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives applying principles of process excellence.
Must have good judgment and ability to take prudent risks.
Expert in metrology for plastic parts, medical devices. – CT, IMM, CMM etc.
Expert in validation DOE’s, IQOQPQ
Background in medical plastic part molding – DC3, etc.
Integrated inspection systems and implementation
Either work for one of our competitors or OEM’s
Solid background in FDA/Regulatory
Expert in designing, building and managing medical device manufacturing quality systems
Skilled in launching full programs start to finish
Bachelor’s degree from four-year accredited university or college required
Work Environment and Physical Demands
Must be able to bend and twist
Must be able to climb stairs
Must be able to stand and stoop
Must be able to lift up to 40 lbs.
The work environment and physical demands detailed above is representative of those encountered while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job. Regular, predicable attendance is required for this position. Attendance is a prerequisite to other job functions.