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Location

Westborough, MA | United States

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Job description

Full job description

Workplace Flexibility: Hybrid

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

We deliver on our purpose and our core values by staying True to Life.

Job Description

We are seeking a senior level leader for the Olympus Digital Unit to head quality and testing related activities as we continue to accelerate our global Digital journey. As a global leader, you will play a key role on our leadership team and will be responsible for our overall quality direction which will include areas such as managing and evangelizing Software Development Lifecycle (SDLC) processes, assessing and improving these in line with industry standards, regulations, and best practices. This role will require close collaboration with stakeholders across multiple functions including corporate QA and RA, product development and testing, privacy, security, program, and product management. The ideal candidate should have a deep understanding of software development in medical device industry, be current on regulations, and understand modern practices for system and software verification, validation, and release methodology. Strong communication, leadership, and negotiation skills along with a proven track record of delivering of software medical devices to the market will help you be successful in this role.

This role requires subject matter expertise in industry standards, including IEC 62304, IEC 82304, ISO 14971, ISO 81001-5-1 among others, as well as in various regulatory domains including FDA, UE-MDR and PMDA. Additionally, this role will lead Digital Unit’s verification and validation processes and activities to ensure that product is released on schedule and on quality.

Job Duties

• Create a “quality” culture within organization by identifying educational opportunities, providing guidance, and interpreting processes and regulations into practical implementations.
• Provide guidance and direction to software development teams on relevant quality processes and practices including SaMD , Cloud, and general health software.
• Collaborate with corporate QA / RA and other stakeholders to develop and maintain Quality Management System documents to ensure appropriate level of controls in conjunction with Agile software development practices.
• Provide leadership to testing teams, understand verification and validation testing methodologies and implement risk based best practices.
• Work with other technical leads within Digital Unit to coordinate processes, activities, and deliverables. Define and support strategic directions and tactical activities. Represent Olympus Digital R&D during internal and external inspection and audits. Establish a response framework for queries and audit findings.
• Collaborate across Olympus to monitor and understand software medical device regulations, guidance, and standards globally, including US, Japan, EU, and UK. Incorporate these, as applicable, into Quality Management System processes and work instructions.
• Understand and lead development team quality and regulatory deliverables during development activities, such as development collaboration and co-creation, beta releases and production releases.

Job Qualifications

Required:

• Bachelor's degree in related discipline, such as quality, information technology, engineering or related is preferred with equivalent experience acceptable. Advanced degree is preferred.
• Minimum of 14 years’ experience in the fields of software development, testing, quality, system engineering or related.
• Knowledge and experience of applications of software related regulations, such as IEC 62304, IEC 82304, ISO 14971, ISO 81001-5-1.
• Experience in creation of internal process documentation, such as SOPs and WI adhering to the government and industry regulations.
• Experience in creating submission materials in various regulatory domains including FDA, UE-MDR and PMDA.
• Occasional travel may be required.

Preferred:

• Software medical device experience preferred.
• Quality management / leadership of software development organization preferred.
• Global experience preferred.
• Demonstrated capabilities to provide quality related leadership to multinational diverse R&D community in a collaborative, coaching, mentoring, and influencing capacity.
• Demonstrated capabilities to work effectively in cross-functional areas such as R&D, Quality, and Regulatory Affairs.
• Experience working on global, matrixed organization is preferred.
• Awareness of system engineering approaches and processes is preferred.
• Experience in application of relevant standards to software as a medical device and healthcare software and software platform.
• Experience in interfacing with Regulatory Authorities is preferred.
• Good understanding of system and software verification and validation processes and testing, including automated and workflow testing, preferably within an agile framework.
• Experience and understanding of risk management process and regulations and practical application of it to software systems.
• Excellent written and verbal communication skills. Ability to clearly communicate expectations, provide clear and honest feedback, and identify areas for improvement.

Why join Olympus?

Here, people matter—our health, our happiness, and our lives.

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive Medical, Dental, Visions coverage effective on start date
• 24/7 Employee Assistance Program
• Free virtual live and on-demand wellness classes
• Work-life balance supportive culture with hybrid and remote roles
• 12 Paid Holidays
• Educational Assistance
• Parental Leave and Adoption Assistance
• Volunteering and charitable donation match programs
• Diversity & Inclusion Programs including Colleague Affinity Networks
• On-Site Child Daycare, Café, Fitness Center**

• US Only

**Limited locations

We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at

About us:

Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.

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

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 [email protected]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Research and Development

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