Process Assurance Coordinator
Working Location: TENNESSEE, BARTLETT
Workplace Flexibility: Onsite
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.
Job Description
The objective of this role is to produce documents that enhance the efficiency and quality of the organization’s operations. This position will involve collaboration with subject matter experts to ensure accuracy, compliance with industry standards, and alignment with the organization’s goals. By fostering an inclusive environment, we aim to leverage diverse perspectives and expertise to achieve optimal outcomes.
Job Duties
- Responsible for the preparation, review, and revision of company Standard Operating Procedures (SOPs), Work Instructions (WIs), and other relevant quality documentation to ensure clarity and compliance.
- Conduct Good Manufacturing Practices (GMP) audits to ensure that the distribution center is maintained in an organized and efficient manner.
- Conduct internal audits and actively participate in all external quality, safety, and environmental audits to uphold compliance standards.
- Identify training needs across the organization and organize training reviews to meet established quality standards.
- Serve as the quality lead on assigned projects, monitoring risk management activities to maximize opportunities for improvement.
- Take the lead in creating and developing recommendations for enhancing existing operational policies, procedures, and processes.
- Collaborate with colleagues to maintain an organized quality training filing system that supports ongoing learning.
- Actively engage in the creation, investigation, and documentation of Corrective Action/Preventive Actions (CAPAs) and Nonconformance Reports (NCRs).
- Log and track CAPAs and NCRs, providing data and insights based on findings to support continuous improvement efforts.
- Support management and team members on continuous improvement methodologies, including Standard Work, 5S, Process Mapping, and Root Cause Analysis.
- Conduct monthly reviews of shipping scales to ensure they are within specified tolerances.
- Coordinate the annual calibration of scales to maintain accuracy in operations.
- Perform other duties as directed to support the overall goals of the organization.
Job Qualifications
Required:
- High school diploma or equivalent.
- Minimum of 1 year of experience in a related field.
- Experience in Documentation: Prior experience in creating Standard Operating Procedures (SOPs), Work Instructions (WIs), and Work Process Aids (WPAs) that enhance operational efficiency.
- CAPA and NCR Experience: Demonstrated experience with Corrective Action/Preventive Action (CAPA) processes and Nonconformance Reports (NCRs) to drive quality improvements.
- Collaborative and Independent Work: Ability to work both independently and collaboratively within diverse teams, fostering a supportive and inclusive work environment.
- Educational Background: High school diploma or equivalent; a degree in a relevant field is preferred.
- Relevant Experience: Minimum of 1 year of experience in a related field, with a focus on analytic reporting or document control.
- Quality Management System Knowledge: Prior experience working within a Quality Management System (QMS) is essential.
- Process Improvement Documentation: Experience in documenting business process improvements, showcasing a commitment to continuous enhancement.
Preferred:
- Six Sigma Green Belt or Lean Six Sigma certification is highly desirable.
- Technical Skills: Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) to support documentation and reporting tasks.
- Continuous Improvement Mindset: A proactive attitude towards identifying opportunities for improvement and implementing effective solutions.
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:
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Competitive salaries, annual bonus and 401(k)* with company match
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Comprehensive medical, dental, vision coverage effective on start date
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24/7 Employee Assistance Program
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Free live and on-demand Wellbeing Programs
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Generous Paid Vacation and Sick Time
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Paid Parental Leave and Adoption Assistance*
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12 Paid Holidays
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On-Site Child Daycare, Café, Fitness Center**
Connected Culture you can embrace:
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Work-life integrated culture that supports an employee centric mindset
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Offers onsite, hybrid and field work environments
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Paid volunteering and charitable donation/match programs
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Employee Resource Groups
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Dedicated Training Resources and Learning & Development Programs
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Paid Educational Assistance
*US Only
**Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefit and incentives.
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 www.olympusamerica.com.
You Belong at Olympus
We value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development.
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.
Posting Notes: || United States (US) || Tennessee (US-TN) || Bartlett || Supply Chain
Job Segment:
Six Sigma, Lean Six Sigma, CAPA, Document Control, Business Process, Management, Administrative