SENIOR MANAGER, CUSTOMER QUALITY EMERGING ISSUES JOB DETAILS | OLYMPUS CORPORATION OF THE AMERICAS

Working Location.
NATIONWIDE   Workplace Flexibility.
Field 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.
**Please note.
All correspondence will be sent from our Olympus domain (@Olympus.
om).
If you receive correspondence from an entity other than @Olympus.
om, it is likely not legitimate.
Job Description The position gathers, collates, maintains, and distributes Emerging Issues list by soliciting input from ship hold, HHA, FCA, regulatory affairs, compliant handling, and product quality teams.
The position will present and communicate Emerging Issus to executive leadership and escalate any issues that require prompt resolution.
The position will track and where needed, facilitate cross-functional team to investigate and develop action plans to resolve the product issue.
The position will review and author responses to requests for additional information from FDA and other regulators on post market topics.
The position will ensure adequate tracking and monitoring of AIRs to facilitate timely implementation and completion of actions, and will also provide routine progress updates.
Job Duties Gathers, collates, and maintains Emerging Issues report; distributes and presents to internal stakeholders.
Responsible for the completion of regulator requests for additional information to the US FDA, and otherRegulatory Authorities as applicable.
Facilitates cross functional teams on investigating, assessing and authoring responses.
Tracks, trends, and analyzes requests for additional information from regulators, respective corrective actions,and remediation.
Identifies issues that require prompt notification and presents/communicates to Olympus senior leadership in a clear and concise manner.
Escalates potential safety issues for risk assessment or health hazard assessment.
Sends leadership urgent or escalated product issue notifications.
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.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Advise management on potential improvements or enhancement to quality systems and processes in the company.
Develops new approaches to solve problems identified as part of the team.
Participates in the implementation of Global Customer Quality initiatives and programs throughout the Global organization, as required.
Participates in the CAPA process as required as an assignee or project team member Job Qualifications Required.
Bachelor’s degree in a science, engineering discipline, or equivalent A minimum of 10 years of related professional experience in the medical device industry.
Requires background and familiarity with applicable regulatory requirements, including but not limited to U.
.
FDA, EU MDD/MDR, ISO , Health Canada, MHLW, ANVISA, and TGA.
Experience in supporting sites / organizations through US FDA, Notified Body, and other International Regulatory Agency Audits.
Experience writing, reviewing, and providing feedback on requests for additional information or audit responses.
Experience working in a global organization and collaborating with multiple regions (Americas, EMEA, APAC, China & Japan) / company locations.
Experience working with, presenting, and communicating with executive leadership.
Experience with implementing tracking and monitoring tools.
Fluent in English language Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones.
International travel up to 25% of the time should be expected   Preferred.
Experience in authoring and managing communications with regulatory agencies preferred.
Experience in problem solving, root cause analysis, and CAPA preferred.
Interpersonal skills to develop and manage good working relationships with all Olympus locations and internal departments (R&D, Manufacturing, Supply Chain, Regulatory, Quality, Regulatory, etc.…).
Proven leadership, teamwork, collaboration and influencing skills.
Ability to work effectively and with agility in a fast paced and dynamic environment.
Working knowledge of problem-solving skills good statistical and analytical skills.
Strong written and verbal communication skills.
Proficient in the use of Information Technology.
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 https://www.
lympusamerica.
om/careers/benefits-perks.
The anticipated base pay range for this full-time position working at this location is $ / year, plus potential for annual bonus (subject to plan eligibility and other requirements).
Olympus considers a variety of factors when determining actual compensation for this position including.
level of experience, working location, and relevant education and certifications.
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 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)