Director, Design Assurance (Japan based

Position: Director, Design Assurance (Japan based)
Location: Center Valley

** Working

Location:

Massachusetts, Westborough*
* ** Workplace Flexibility:
Remote*
* ** _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:
.

** Job Description*
* Quality leader providing strategy, execution, oversight, training and mentoring to the organization for new product development, sustaining/lifecycle engineering, risk management and end to end product quality.

Directly responsible for the Sustaining Design Assurance Organization in Hachioji (Ishikawa) Japan, with potential indirect reports in Hyderabad, India as deemed appropriate based on business needs. This includes Product Development Quality Engineering, Risk Management, and CAPA engineers.

** Job Duties*
* + Mentors and leads the Hachioji, Japan Sustaining Design Assurance Engineering staff supporting new product development and sustaining engineering projects across GI, GI-ET, and GI-EUS products.

+ Champion and subject matter expert for customer and patient focused end to end Risk Management.

+ Supports all aspects of the product lifecycle for products in scope, including sustaining activities, design change management, complaint investigations and ongoing risk management activities/post market surveillance.

+ Supports facility audits by outside agencies (i.e., FDA, ISO / MDSAP) and acts as a subject matter expert to demonstrate compliance to regulatory requirements and the Olympus Quality System.

+ Stakeholder and collaborator with senior management relating to project, process, business, and quality decisions.

+ Supports EUMDR and other state of the art regulatory standard requirements.

+ Support for Hachioji quality records, including but not limited to CAPAs, Nonconformances, post market risk assessments, HHA, and relevant internal and external audit findings.

+ Other Quality responsibilities, delegations and special projects as assigned by Management.

** Job Requirements*
* *
* Required:

*
* + BS degree or equivalent in engineering or life science discipline.

+ Minimum of 10-15 years of professional experience or equivalent training or equivalent training/education in quality or other engineering discipline.

+ Minimum of 5 years working in medical device new product development management position(s) and people leadership.

+ Proven track record in the global execution of New Product Development delivering on robust, customer and patient focused product quality, Concept through Post-Launch for WW markets.

+ Strong technical skills related to Design Assurance including VOC translation to Design Inputs and Outputs, Human Factors, CTQ Cascades, Design Characterization, Verification / Validation, Test Method Validation, Process Validation, Inspection Techniques and Statistics.

+ Ability to drive value and product differentiation through the Design Assurance Team.

+ Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the Med Tech industry e.g., ISO, QSR, GMP, GLP, GCP, HIPAA, Design Controls, Human Factors, Risk Management practices.

+ Strong working knowledge of technical problem-solving skills.

+ Strong collaboration and influencing skills and the ability to work across functions.

+ Must be a change agent, highly and effectively organized, be a flexible self‑starter, team-oriented and excellent at prioritization and multitasking.

+ Strong track record of product and process continuous improvement is required.

+ 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 attitude and a desire to improve patient and customer experience as well as company performance.

+  
** This role is…