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Global Director QARA Compliance: Audit Operations

Req ID:  7804

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

Leads and directs a team of 3 Quality Engineers responsible for ensuring compliance with the Internal Audit process as it pertains to closing out internal audit findings in a timely manner and ensuring that corrections and corrective actions are appropriate. Responsible for KPI Trending, Monthly Internal Audit Reporting, and for identifying significant trends found within the internal and external audit programs.  The team will be responsible for communications to executive management regarding trends and progress reports on a monthly, quarterly, and yearly basis. The position will drive change within the organization resulting in a strong organization that is able to react to audit findings in a timely manner. 

 

The group is responsible for maintaining a robust internal auditor training program and site level auditor certifications that results in increased auditing capabilities. 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

  • Lead a team of 3 or more Quality Engineers
  • Track, Trend and Report on Internal Audit Metrics
  • Identify trends and significant triggers from the audit program and report to Executive Management 
  • Responsible for monthly group report and KPI metrics analysis 
  • Work closely with the Sites and Functions on audit report corrections and corrective actions
  • Interacts internally within Olympus at all levels, including the C Suite
  • Challenged with influencing culture around internal audit responses and timely execution of actions

Job Qualifications

Required:

  • Bachelor’s degree in a science, engineering discipline, or equivalent required
  • A minimum of 15 years’ experience of related professional experience and in medical device industry
  • A minimum of 5 years managing a team in the medical device industry
  • Experience working with C-Suite executives.
  • 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 20 % 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. 
  • Proficient 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 https://www.olympusamerica.com/careers/benefits-perks.

        

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 www.olympusamerica.com.

 

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) 


Job Segment: QA, Quality Assurance, Manager, Engineer, Technology, Quality, Management, Engineering

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