Director, Design Assurance

Req ID: 10741

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: https://www.olympusamerica.com/careers.

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 MedTech 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.
Up to 10% domestic travel.

Preferred:

MBA or other advanced degree strongly preferred.
Design or Process Black Belt is a plus.
Strong working knowledge of six sigma methodologies is a plus.

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
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 benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.

The anticipated base pay range for this full-time position is $154,866.00 - $216,812.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual.

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.

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 31,000 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 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

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.

Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)

Job Segment: Six Sigma Black Belt, Six Sigma, Quality Assurance, QA, Engineer, Management, Technology, Quality, Engineering

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