Global Document Control Specialist - Remote

Olympus Corporation of the Americas; Center Valley (Lehigh County); Remote; USD 60,000 - 80,000; Full time

Job summary

An innovative medical technology company is seeking a Global Document Control Specialist to manage and maintain critical company documents. This role ensures the accuracy, quality, and integrity of documents while supporting regulatory compliance and change processes. You will work closely with various teams to facilitate document control and training, contributing to the overall efficiency of the organization. Join a forward-thinking firm that values integrity, innovation, and empathy, and make a meaningful impact in the healthcare sector while enjoying a supportive work environment with flexible options.

Benefits

Competitive salaries

Annual bonus

401(k) with company match

24/7 Employee Assistance Program

Free Wellbeing Programs

Generous Paid Vacation

Paid Parental Leave

On-Site Child Daycare

Fitness Center

Paid volunteering programs

Qualifications

• 3-5 years of document control experience in a regulated industry preferred.
• Strong knowledge of ISO 13485:2016 and FDA Quality System Regulation.

Responsibilities

• Manage and maintain Global Quality Management Systems documents.
• Support change activities and ensure compliance with regulations.

Skills

Document Control

Regulatory Compliance

Attention to Detail

Time Management

Communication Skills

Education

BS Degree

Tools

QMS Systems

Job description

Global Document Control Specialist - Remote

Working Location: PENNSYLVANIA, CENTER VALLEY

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.

Job Description

The Global Document Control Specialist manages and maintains company documents, ensuring their accuracy, quality, and integrity, while ensuring the company adheres to record retention policies and safeguards information. Responsible for supporting the change process including change assessments. Maintains the company’s document control process, lifecycle procedure including record requirements and ongoing improvement and/or maintenance of procedures and processes.

Job Duties

• Manage, publish and maintain Global Quality Management (QMS) Systems documents while also ensuring their accuracy, quality, and integrity.
• Responsible for supporting the release and change activity for the Global QMS, receiving and processing requests for changes and updates. Communicate effectively with Change Requestor and Process Stewards/Subject Matter Experts (SMEs) throughout the lifecycle of a change.
• Perform all document and record responsibilities, including change control per the Global QMS procedure(s).
• Establish support and awareness to Change Requestors in defining changes, evaluating the impact of the change, and measuring adoption.
• Reviews completeness of documentation ensuring compliance with all relevant regulations and standards.
• Plan and prepare periodic reviews for the Global QMS documents.
• Facilitates implementation assessments (and/or reviews) for deployments to determine document control & training impact to ensure first time right.
• Ensure functional groups and Global Process Stewards adhere to the company’s document control procedures.
• Train employees new to the doc control process as required.
• Establish, monitor, and respond to metrics on the efficacy and efficiency of the document management and training system and its ability to support the business.
• Provide access to systems as required.
• Timely distribution of latest revision level documentation to all users and ensure that obsolete documentation is removed from distribution.
• Acts as SME for document, record, and change control processes.
• Functions as system expert for tools related to document and record control.
• Work across multiple functions and businesses to resolve issues.
• Assist with file migrations and audits and perform administrative tasks as needed.
• Other Essential Duties as directed.

Job Qualifications

Required:

• Minimum of 3-5 years related document control experience in a regulated industry (medical device is preferred).
• Excellent understanding and working knowledge of appropriate global regulations, requirements, and standards such as ISO 13485:2016, ISO 9001:2015 and FDA Quality System Regulation.
• Excellent working knowledge of document control standards and systems.
• Strong attention to detail.
• Ability to prioritize, manage time well, multi-task, and troubleshoot.
• Strong verbal and written communication skills, with the ability to interact with all levels of the organization.
• Travel to other company (regional) facilities may be required, up to 5%.

Preferred:

• BS Degree preferred or demonstrated equivalent experience.

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
• 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

The anticipated base pay range for this full-time position working at this location is $21.71-$28.22/ hour, 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 [e-mail]. 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)