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Principal Quality Engineer AIR

June 4, 2026

Working Location: Nationwide 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: <a href="https://www.olympusamerica.com/careers">https://www.olympusamerica.com/careers</a>.<div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><h2 style="font-size:1.0em;margin:0.0px">Job Description</h2> </div><div>The Principal Quality Engineer is responsible for driving complex projects to completion by effectively managing all aspects related to such initiatives within the Quality organization. Primary focus will be on facilitating cross-functional team process improvements, developing actions, and tracking, where needed, to meet defined objectives while satisfying regulatory requirements and business strategy. This position requires a global outlook and the ability to integrate many different aspects of the organization, such as functions, departments, software platforms, etc. to ensure the project satisfies various stakeholders and areas of the business.</div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><h2 style="font-size:1.0em;margin:0.0px">Job Duties</h2> </div><div><ul> <li>Supports the development and implementation of the global regulatory requests for additional information communication process and activities.</li> <li>Supports and monitors the completion of regulator requests for additional information to the US FDA, and other Regulatory Authorities as applicable.</li> <li>Supports and contributes in cross functional teams on investigating, assessing and authoring responses.</li> <li>Tracks, trends, and analyzes requests for additional information from regulators, respective corrective actions, and remediations; provide inputs to upstream processes for improvements.</li> <li>Gathers, collates, and maintains AIR weekly report; distributes and presents to internal stakeholders.</li> <li>Identifies issues that require prompt notification and presents/communicates to Olympus senior leadership in a clear and concise manner.</li> <li>Escalates potential safety issues for risk assessment or health hazard assessment.</li> <li>Supports and contributes the development of Global AIR communications.</li> <li>Works together with the Customer Quality organization to identify, access, and analyze data that have impact on the company’s compliance with overall quality systems.</li> <li>Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.</li> <li>Advise management on potential improvements or enhancement to quality systems and processes in the company.</li> <li>Develops new approaches to solve problems identified as part of the team.</li> <li>Participates in the implementation of Global Customer Quality initiatives and programs throughout the Global organization, as required.</li> <li>Participates in the CAPA process as required as an assignee or project team member.</li> <li>Perform other duties as assigned.</li> <li> </li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><h2 style="font-size:1.0em;margin:0.0px">Job Qualifications</h2> </div><div>Required: <ul> <li>Bachelor's degree in a science, engineering discipline, or equivalent.</li> <li>Minimum 8 years in medical device industry or equivalent such as pharmaceutical, healthcare, or related.</li> <li>Experience leading projects with a focus on process improvement and data analytics.</li> <li>Proven ability to lead and manage cross- functional teams effectively communicate with all levels of management and drive effective change.</li> <li>Requires background and familiarity with applicable regulatory requirements, including but not limited to U.S.FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA.</li> <li>Experience in supporting sites / organizations through US FDA, Notified Body, and other International Regulatory Agency Audits.</li> <li>Experience writing, reviewing, and providing feedback on requests for additional information or audit responses.</li> <li>Experience working in a global organization and collaborating with multiple regions (Americas, EMEA, APAC, China & Japan) / company locations.</li> <li>Experience working with, presenting, and communicating with executive leadership.</li> <li>Experience with implementing tracking and monitoring tools.</li> <li>Fluent in English language</li> <li>Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones. International travel up to 20% of the time should be expected.</li> </ul></div></div></div>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: <ul> <li> Competitive salaries, annual bonus and 401(k)* with company match </li> <li> Comprehensive medical, dental, vision coverage effective on start date </li> <li> 24/7 Employee Assistance Program </li> <li> Free live and on-demand Wellbeing Programs </li> <li> Generous Paid Vacation and Sick Time </li> <li> Paid Parental Leave and Adoption Assistance* </li> <li> 12 Paid Holidays </li> <li> On-Site Child Daycare, Café, Fitness Center** </li> </ul> Connected Culture you can embrace: <ul> <li> Work-life integrated culture that supports an employee centric mindset </li> <li> Offers onsite, hybrid and field work environments </li> <li> Paid volunteering and charitable donation/match programs </li> <li> Employee Resource Groups </li> <li> Dedicated Training Resources and Learning & Development Programs </li> <li> Paid Educational Assistance </li> </ul> *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: <a href="https://www.olympusamerica.com/careers/benefits-perks">https://www.olympusamerica.com/careers/benefits-perks</a>. The anticipated base pay range for this full-time position is $106,402.00 - $148,963.00 / 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 <a style="color:#0563c1;text-decoration:underline" href="https://www.olympusamerica.com/">www.olympusamerica.com</a>. 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. <div> </div> Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...

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