Working Location: MASSACHUSETTS, WALTHAM 

 

Are you looking for a company that cares about people’s lives and health, including yours? At EVIDENT, we help make people’s lives healthier, safer and more fulfilling, every day.

 

Let’s inspire healthier lives, together.

Job Description

The Executive Director, Quality and Regulatory Affairs (Exec Dir QARA), will oversee the Quality, Regulatory and Environmental Health and Safety (EHS) systems across all EVIDENT manufacturing sites and design centers. This position will also be a member of the EVIDENT Management Committee. Functioning in a matrix management environment and managing the Quality, Regulatory Affairs functions, the Exec Dir QARA has responsibility for leading the NDT, RVI and ANI strategic quality plan in collaboration with the EVIDENT Management Team. The Exec Dir QARA is responsible for 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 EVIDENT products. Results are achieved through associates who are committed to a culture of regulatory compliance, high quality, continuous improvement, safety, and customer focus. 

Job Duties

• 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.
• 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 alert 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 both software and hardware.
• 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 organization, including Evident Tokyo and other Evident businesses to ensure overall quality and regulatory compliance.
• Inspire, motivate and communicate vision to associates, peers, EVIDENT leadership and build consensus toward adoption of and commitment to appropriate standards for quality in support of the Respiratory market needs and business goals.
• Determine and develop quality and compliance competencies and skills needed for the on-going success of the EVIDENT business.
• Retain and manage developing successors for critical positions.
• Create and sustain the culture of customer focused innovation, efficiency and balanced risk management.
• Develop and implement a clear customer centric vision for Quality. Lead, Inspire and communicate vision to internal and external leaders across the organization.
• Develop partnerships and alliances across the global Evident business.
• Design Assurance, Operations Quality, Risk Management, Regulatory Compliance, Complaint Handling

Job Requirements

EDUCATION AND/OR EXPERIENCE

• Minimum of 10 years quality management with at least 5 years of senior management experience.
• Technical aptitude and background in electromechanical, software driven devices preferred.
• Bachelors Degree or equivalent experience required.

ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES

• Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to our industry e.g., ISO,
• All regulatory compliance aspects of industrial devices
• Design assurance/control and operations quality.
• Demonstrated expertise in the design, implementation and measurement of quality systems and metrics.