Senior Manager, Quality Audit Operations

Working Location: PENNSYLVANIA, CENTER VALLEY

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

Responsible for developing, executing, and maintaining a program to train and certify Olympus's internal auditors at all levels within the organization. The program will successfully increase internal auditing competencies resulting in a robust internal audit program that identifies quality system compliance gaps within the organization. The role will participate in and partner with peers to monitor and react to internal and external audit KPI metric triggers and will be a contributing member of the team managing internal audit trending and reporting. The position will help drive change within the Olympus organization resulting in a robust and capable internal audit program. Knowledge in applicable global regulatory requirements, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA.

Job Duties

• Develop, maintain and execute the training and certification programs for Internal Auditors at all levels of the Olympus organization.

• Track, Trend and Report on Training Metrics

• Identify trends and significant triggers from the audit program that indicates gaps in competency and capabilities training requirements.

• Responsible to participate in monthly group report and KPI metrics analysis.

• Work closely with the Sites and Functions on the auditor training program

• Responsible for any 3rd party internal auditor training program relationship, including SOW and PO management and approvals.

• Interacts internally within Olympus at all levels.

• Challenged with influencing culture around internal and external audits.

Job Qualifications

Required:

• Bachelor's degree in a science, engineering discipline, or equivalent required.

• A minimum of 7 years' experience of related professional experience and in medical device industry, preferably in an auditing capacity

• 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.

• Experience in supporting sites / organizations through US FDA, Notified Body, and other International Regulatory Agency Audits.

• Experience writing, reviewing, and providing feedback on internal audit responses.

• Experience working in a global organization and collaborating with multiple regions (Americas, EMEA, APAC, China & Japan) / company locations.

• Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones. International travel up to 10 % of the time should be expected.

Preferred:

• Proven leadership, teamwork, collaboration and influencing skills.

• Ability to work effectively in a fast paced and dynamic environment.

• Working knowledge of problem-solving skills good statistical and analytical skills.

• Strong written and verbal communication skills.

• Pro?cient in the use of Information Technology.

• Fluent in English language

• 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....).

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.

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