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Principal QE Engineer QA/RA Compliance - External Audit

Req ID:  6860

Working Location: Missouri, St. Louis; 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.

Job Description

Provide Quality Engineering support to ensure compliance with the Global Quality System regulatory requirements and the business strategy of the company. Represents Global QA&RA Compliance as a team member to support development and implementation Global external audit process, programs, and activities. Member of Global Audit Support Function established as a dedicated team to implement Global External Audit Process and provides all Olympus sites support for external audit related activities, improving outcomes and efficiencies. Can serve as a backup to the Director Global QA&RA Compliance, External Audit.

Job Duties

  • Global QA&RA Compliance team member that supports development and implementation of Global external audit process, programs, and activities. Leads or participates in the development of process and procedure development/changes. Provides guidance to other QE within the group.
  • Provides support for all Olympus external quality audits and leads/supports the development of external audit training programs, resources, and tools, improving audit execution, outcomes, and efficiencies.
  • Leads the development of external audit responses, facilitates completion, and delivery of responses to the US FDA, Notified Bodies, and other authorities. Supports the development and implementation of a Global audit response process.
  • Supports the development and implementation of new monitoring and reporting tools that measure progress of external audit schedules and audit outcomes. Identifies, accesses, and analyzes data that have impact on the company’s compliance to overall quality systems. Tracks, trends, and analyzes external audit findings, corrective actions, and remediations. Make recommendations based on areas of highest compliance risk.
  • Supports the development and implementation of Global audit readiness programs and tools that improve site audit readiness (compliance and audit support) and assesses likelihood of future audits.
  • Participant in Global External Audit Communities of Practice.
  • 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. Assist in the implementation of Global QA&RA Compliance initiatives and programs throughout the Global organization.
  • Participates in the CAPA process as required as an assignee or project team member.

Job Qualifications

Required:

  • Bachelor’s degree in engineering discipline or equivalent.
  • Minimum of 8 years related experience and in medical device industry.
  • 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 audit responses, is highly valued.
  • 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…).
  • 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.
  • Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones. Domestic and international travel up to 40% of the time should be expected.

 

#LI-Remote

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) || Missouri (US-MO) || St. Louis || 


Nearest Major Market: St Louis

Job Segment: QA Engineer, Quality Assurance, QA, Medical Device Engineer, Engineer, Engineering, Technology, Quality

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