Sr. Director, Design Assurance

Working Location: PENNSYLVANIA, CENTER VALLEY 

Workplace Flexibility: Field

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our Purpose: 

 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus.

 

 

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.