Quality Assurance Analyst - Global Ship Hold Center (GSHC)

Req ID: 9099

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 Assurance Analyst – Global Ship Hold Center (GSHC) is an exciting, multi-faceted position that requires an effective candidate with varied skills and abilities. This role will be overseeing and maintaining the quality and compliance of GSHC delivery and records, with a strong emphasis on adherence to GDP, quality documentation, system workflows, and relevant compliance policies. It involves reporting, analyzing, and evaluating GSHC records for quality and compliance. The Quality Assurance position will interact with teams in several different locations in and outside of the country.

Job Duties

Monitor and manage current global ship hold process ensuring adherence to the established processes and clearing bottlenecks with workflow & approval flows.
Administrator for the Microsoft Power Application, GSHC – Manage email/workflow communication group; provide application access rights to requesters.
Write test scenarios & scripts and perform user acceptance testing.
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. Analyze data to identify patterns, trends, anomalies, create reports, and interpret/explain data and to solve problems
Manage application documentation and record reconciliation; training materials; Standard Operating Procedures and Work Instructions.
The Quality Assurance Analyst plays a significant role in ensuring the organization's GSHC records and processes operate with efficiency, effectiveness, and compliance with quality and regulatory standards. Additionally, this role entails ensuring that GSHC complies with required quality standards, such as the FDA Quality System Regulation and ISO 13485.
In this role, you will report to the Director of Global Ship Hold Center, and will work closely with the following groups:
- Quality Assurance/Regulatory Affairs (QA/RA): Ensures compliance with quality standards and regulatory requirements.
- Supply Chain Management (SCM): Enhances efficiency in the supply chain by preventing disruptions.
- Warehouse & Distribution Centers: Facilitates better management of inventory and timely product release.
- Executive Management: Provides leadership with comprehensive insights into global ship hold activities.
- Compliance Audits: Supports seamless and transparent compliance audits through centralized data management.
Audit to GSHC processes and policies as it pertains to the Quality Management System (QMS).
Serve as a Subject Matter Expert (SME) and point of contact for all GSHC activities,
Report, troubleshoot, monitor, and manage the open Ship Holds in the GSHC Application to ensure process compliance.
Manage reporting and create dashboards to support performance accuracy and identify trends. Recommend and assist in creating materials for presentations, communications, and meetings/training as well as delivering training.
All duties as assigned.

Job Qualifications

Required:

Bachelor’s degree in business or equivalent knowledge required.
Minimum of 2 years’ experience working in a regulated environment such as FDA, ISO 13485, and/or medical device company required.
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:

Familiarity with Power Platform as well as developing dashboards utilizing Power BI reporting or willingness to learn.

Experienced in working with software systems and preferably have knowledge of ERP Systems.
Knowledge of FDA regulations, ISO 13485 and HIPAA for medical devices preferred.
Quality auditing skills preferred.
Adept in robust troubleshooting and analytic skills, coupled with an extraordinary attention to detail.
Effective written and verbal communication skills, including process writing.

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)

Job Segment: QA, Quality Assurance, Testing, ERP, Technology, Quality

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