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Career Opportunities: Quality and Process Improvement Coordinator - Global Ship Hold Center (GSHC) (9126)

Remote: 
Full Remote
Salary: 
62 - 84K yearly
Experience: 
Mid-level (2-5 years)
Work from: 
United States

Offer summary

Qualifications:

Associate's degree in quality or related field preferred., Proficiency in Microsoft Office required., 3 years experience in a regulated environment preferred., Knowledge of FDA regulations and ISO preferred..

Key responsabilities:

  • Oversee quality and compliance processes.
  • Coordinate inventory transactions and process improvements.
Olympus Corporation of the Americas logo
Olympus Corporation of the Americas XLarge https://www.olympusamerica.com/
5001 - 10000 Employees
About Olympus Corporation of the Americas
At Olympus, we put a lot of good back into the world, and what we do, really matters. We are committed to making people’s lives healthier, safer and more fulfilling every day by crafting innovative optical and digital solutions in medical technologies; life sciences; industrial solutions; and cameras and audio products. Everything we do at Olympus is a reflection of our vision, and everyone here helps to make it a reality. We view our relationship with and commitment to our employees with the same passion. Everything we do at Olympus is a reflection of our purpose and everyone here helps to make it a reality. We’re invested in our employees, great ideas, and how they impact the communities around us. We see the world through multiple lenses and come together to find the right answers; the best solutions. Olympus Corporation of the Americas (OCA)—a wholly owned subsidiary of Olympus Corporation in Tokyo, Japan—is headquartered in Center Valley, Pennsylvania, and employs more than 5,300 people at our locations throughout North and South America. Join us! True To You. True To Society. True To LIFE.
See more Olympus Corporation of the Americas offers

Job description

 

Working Location: NATIONWIDE 

Workplace Flexibility: Field

 

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.

 

**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

 

 

Job Description

The role of a Quality and Process Improvement Coordinator – Global Ship Hold Center (GSHC) is overseeing and maintaining the quality and compliance of GSHC delivery GSHC records, with a strong emphasis on adherence to GxP, quality documentation, system workflows, and relevant compliance policies. This role also acts as liaison between RA/QA, Business Groups, Outbound and Inbound staff to coordinate all physical and system inventory transactions that pertain to regulatory issues, Warehouse Management System/ERP Item Master updates, shortages, returned inventory, damages/disposals, slotting, location type availability and size to improve efficiencies while maintaining Inventory Integrity.

Job Duties
  • Monitor and manage current global ship hold process ensuring adherence to the established processes and clearing bottlenecks with workflow & approval flows.
  • Responsibilities include recognizing opportunities to enhance process and/or system monitoring, identifying issues, and proposing potential solutions. The GSHC team will function to provide key performance indicators (KPIs) used for process monitoring and management reviews.
  • Utilize Microsoft Power Platform to help drive process improvement.
  • Manage application documentation and record reconciliation; training materials; Standard Operating Procedures and Work Instructions.
  • Address and coordinate with RA/QA on quality issues which include verifying, segregating and returning stock where applicable.
  • Process Return to Vendor and Destruction orders as requested. Coordinate receipt of all necessary paperwork needed to initiate and confirm destruction orders.
  • Handle the internal product transfers shipments for disposition of Ship Hold Materials.
  • Work on problems of moderate scope where analysis of situations or data may be required.
  • Collaborate with cross-functional teams to design and implement process improvement initiatives.
  • Build productive and stable working relationships with internal functional teams and may interact with cross-functional teams with some support and supervision from senior team members.
  • Provide training and support to staff on quality standards and best practices.
  • Serve as a Subject Matter Expert (SME) and point of contact for all GSHC activities
Job Qualifications

Required:

  • Associate’s degree in quality or a closely related field or combination of education and relevant experience.  Bachelor’s degree in quality, or business or equivalent knowledge is preferred.
  • Proficiency in Microsoft Office, including Excel, Word, PowerPoint, and Visio is required.
  • Role is Global and can be performed as a #LI-Remote in USA or Europe.

 

Preferred:

  • Minimum of 3 years’ experience working in a regulated environment such as FDA, ISO 13485, and/or medical device company is preferred.
  • Demonstrate strong project management and organizational skills, multitasking ability, and work effectively with internal stakeholders across functions.
  • Familiarity with Power Platform as well as developing dashboards utilizing Power BI reporting or willingness to learn.
  • Knowledge of FDA regulations, ISO 13485 and HIPAA for medical devices preferred.
  • Adept in robust troubleshooting and analytic skills, coupled with an extraordinary attention to detail.
  • Effective written and verbal communication skills, including process writing.
  • Working knowledge and understanding of Warehouse Management Systems and ERP Systems with the ability to learn and adapt to a new system as applicable.
  • Must have a positive attitude, excellent communication skills with focus on teamwork and rapid problem resolution.
  • Analytical Skills, Problem Solving, Mathematical Skills, Organizational Skills.
  • Autonomy in work execution.
  • Quality auditing skills preferred.

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:

 

  • Competitive salaries, annual bonus and 401(k)* with company match

  • Comprehensive medical, dental, vision coverage effective on start date

  • 24/7 Employee Assistance Program

  • Free live and on-demand Wellbeing Programs

  • Generous Paid Vacation and Sick Time

  • Paid Parental Leave and Adoption Assistance*

  • 12 Paid Holidays

  • On-Site Child Daycare, Café, Fitness Center**

 

Connected Culture you can embrace:

 

  • Work-life integrated culture that supports an employee centric mindset

  • Offers onsite, hybrid and field work environments

  • Paid volunteering and charitable donation/match programs

  • Diversity Equity & Inclusion Initiatives including Employee Resource Groups

  • Dedicated Training Resources and Learning & Development Programs

  • 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.

 

The anticipated base pay range for this full-time position working at this location is $62,499.00 - $84,374.00 / 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. 

 

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.

 

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 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).

 

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

 

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Process ImprovementQuality ManagementRegulatory ComplianceProject ManagementWarehouse Management SystemsQuality AuditingERP Systems KnowledgeMicrosoft Power PlatformISO 13485 StandardPower BIFDA Regulations

Other Skills

  • Microsoft Office
  • Problem Solving
  • Communication
  • Analytical Skills
  • Organizational Skills
  • Detail Oriented
Are you interested?

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