Executive Director, Design Assurance

Job Description

The role will develop and oversee the following processes in support of the Global Design Assurance team:

• Oversight over the global risk management process, including global harmonization and effective training tools to deploy to cross-functional collaborating team members
• In collaboration with the CTO organization, develop, deploy and educate staff on compliant and globally harmonized design control processes
• Establish consistency in the application of statistics throughout the design control processes and adjacent processes as it relates to effective engineering principals as well as design verification and validation
• Management of governance and operating mechanisms focused on driving product Quality and Compliance objectives.
• Oversight of Quality Data and actions to implement improvements across the Olympus product portfolio.
• In collaboration with Olympus Quality Systems and Compliance organizations, develop and implement compliance strategy designed to lower regulatory burden and compliance risk for ESD organization.

The role works closely with other functions and strategic partners such as R&D, Manufacturing, Medical Safety, and Regulatory Affairs to establish, drive, and achieve excellence in product development initiatives, as well as leading cross-functional failure analysis teams to quickly and effectively identify root causes for escalated issues.

The role will design and build a strong and data driven organization equipped with world-class competencies to enable and deliver on Olympus business, Quality and Compliance objectives. This includes internal teams located across the Americas, EMEA, Japan and APAC as well as third-party support teams located off-shore.

Job Duties

The role will focus on building and developing the following key competencies and processes:

• Six Sigma black belt a plus.
• Expected to understand strategic priorities developed by executive management and to respond to requests with appropriate urgency and with an organized approach.
• Ability to operate independently and highly autonomously, holding him/herself accountable to proactively fulfill tasks and achieve results within assigned timelines. Provides solutions to highly complex, and significant issues; develops solutions based on in-depth technical knowledge, company policies, or defined process paths.
• Knowledge of national and international regulations applicable to medical devices including but limited to; Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC
• Ability to analyze and interpret all regulatory and quality guidelines needed
• Demonstrate a strong “business partner” approach and attitude providing creative and innovative solutions that meet quality standards
• Thinks “Out of the Box” to optimize Quality goals and business value.
• Ensures that improvement objectives are based on strong analytical foundation and established a structure, foundation and governance for transparent and actionable quality and compliance data.
• Works across functions to establish improvement programs focused on improving Quality, Compliance and Customer satisfaction.
• Provides inspection and audit support to various Olympus sites.
• Proactively identifies and alerts organization of quality issues/complaints in time to resolve potential adverse effects to the customer, company image/reputation and/or the business.
• Develops and maintains Design Quality Data Scorecard to ensure transparency across the portfolio.
• Builds governance and process to ensure actions are taken across the organization based on adverse trends.
• Works closely with Compliance and RA organization to identify and act on regulatory trends requiring changes to QMS, products or processes.
• Build and implement a strategy to improve Quality Mindset and Quality Culture throughout the organization.
• Develop, build and maintain a strong Six Sigma / Lean organization focused on implementing continuous improvement programs to support product development teams.
• Mentors, manages, and develops direct reports.

Job Qualifications

Required:

• Bachelor’s degree or equivalent in a Life Science focus, Engineering, or Physical Science required with an advanced technical degree and MBA preferred.
• Minimum of 15 to 20 years of experience in quality management or design assurance with at least 5-7 years of management experience in a global position in a regulated environment in the MedTech industry.
• Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry such as: ISO, QSR, GMP, GLP, GCP, HIPAA.
• Demonstrated expertise in the design, implementation and measurement of quality systems and metrics.
• 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.
• Since this is a Global role, the individual will be expected to schedule meetings that work for multiple time zones and well as 20 to 40% travel should be expected.

Preferred:

• Out of box" strategic thinker with strong leadership ability.
• As a change agent, motivated to improve organization and not be satisfied with status quo.
• Experienced in initiating, cultivating and embedding a cultural change in a complex and diverse Olympus organization.
• Excellent interpersonal and leadership skills with diverse cultural approach.
• A self-starter motivated and able to positively motivate others. Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside Olympus.
• Focused, target driven with a positive, can-do attitude and a desire to improve patient experience as well as company performance.
• Excellent writing and verbal skills