Olympus America Inc. Executive Director, Regulatory Affairs & Quality Assurance in Waltham, Massachusetts

Job Description

Waltham, MA - The Executive Director, Quality and Regulatory Affairs (Exec Dir QARA), will oversee the Quality, Regulatory and Environmental Health and Safety (EHS) systems across all OSSA/ONDT manufacturing sites and design centers. The incumbent will also be a member of the OSSA Management Committee. Functioning in a matrix management environment and managing the Quality, Regulatory Affairs and EHS departments, he/she has responsibility for leading the NDT and ANI strategic quality plan in collaboration with the OSSA Management Team. The incumbent 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 OSSA products. Results are achieved through associates who are committed to a culture of regulatory compliance, high quality, continuous improvement, safety, and customer focus. EOE Minorities/Females/Veterans/Disabled

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.

  • Maintain responsibility 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 Olympus Tokyo and other Olympus businesses to ensure overall quality and regulatory compliance. Inspire, motivate and communicate vision to associates, peers, OSSA 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 OSSA 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 Olympus business.

  • Maintain responsibility for Design Assurance, Operations Quality, Risk Management, Regulatory Compliance, Complaint Handling and EHS.

  • Perform all other essential duties as assigned.

Job Requirements:

  • Bachelors Degree or equivalent experience is required.

  • Minimum of 10 years of quality management experience with at least 5 years of senior management experience.

  • Technical aptitude and background in electromechanical, software driven devices preferred.

  • 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.

  • 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.

  • Must be able and willing to travel 25% of time.

Supervisor Responsibilities

  • Director, EHS & Regulatory Affairs

  • Quality Analyst

Auto req ID 2631BR

Posting Title Executive Director, Regulatory Affairs & Quality Assurance

Company URL Olympus Corp of the Americas at http://www.olympusamerica.com/

About Us Olympus Corporation of the Americas, with headquarters in Center Valley, PA is a precision technology leader, creating innovative opto-digital solutions in health care, life science and consumer electronics products throughout North America. Olympus works collaboratively with its customers and its affiliates worldwide to leverage R&D investment in precision technology and manufacturing processes across diverse business lines. These include: gastrointestinal endoscopes, accessories, and minimally invasive surgical products; advanced clinical and research microscopes, digital cameras and voice recorders. Olympus Corp of the Americas at http://www.olympusamerica.com/

Posting Locations Massachusetts, Waltham

Olympus is an Equal Opportunity Employer, and our policies prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification.