EXECUTIVE DIRECTOR, DESIGN ASSURANCE JOB DETAILS | OLYMPUS CORPORATION OF THE AMERICAS

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.
​ ​ ​ 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.
​ Our five Core Values empower us to achieve Our Purpose.
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus.
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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 CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO , ISO , and MDD /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 Why join Olympus?   We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on.
Competitive salaries, annual bonus and 401(k)* with company match Comprehensive medical, dental, vision coverage effective on start date 24/7 Employee Assistance Program Free live and on-demand Wellbeing Programs Generous Paid Vacation and Sick Time Paid Parental Leave and Adoption Assistance* 12 Paid Holidays On-Site Child Daycare, Café, Fitness Center**   Connected Culture you can embrace.
Work-life integrated culture that supports an employee centric mindset Offers onsite, hybrid and field work environments Paid volunteering and charitable donation/match programs Diversity Equity & Inclusion Initiatives including Employee Resource Groups Dedicated Training Resources and Learning & Development Programs Paid Educational Assistance   *US Only   **Center Valley, PA and Westborough, MA     Are you ready to be a part of our team?   Learn more about our benefit and incentives.
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling.
As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than employees worldwide in nearly 40 countries and regions.
Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than employees throughout locations in North and South America.
For more information, visit www.
lympusamerica.
om.
Olympus is dedicated to building a diverse, inclusive and authentic workplace   We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect.
We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
Let’s realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Applicants with Disabilities.
As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone.
If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at .
If your disability impairs your ability to email, you may call our HR Compliance Manager at -Olympus ().
Posting Notes.
|| United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)