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Global Senior Document Control Specialist

Company

Olympus Corporation of the Americas
Address , Brooklyn Park, 55445, Mn
Employment type
Salary
Expires 2023-10-02
Posted at 9 months ago
Job Description

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.

The Global Senior 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

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

Job Qualifications

Required:

  • Strong attention to detail.
  • Demonstrated experience working in with cross-functional teams on simultaneous projects.
  • Ability to prioritize, manage time well, multi-task and troubleshoot.
  • Travel to other company (regional) facilities may be required, up to 5%.
  • BS Degree required
  • Strong verbal and written communication skills, with the ability to interact with all levels of the organization.
  • Excellent working knowledge of document control standards and systems.
  • 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.
  • Minimum of 7 years related document control experience in a regulated industry. Medical Device experience is preferred.


#LI-Remote

Why join Olympus?

Here, people matter—our health, our happiness, and our lives.

  • Educational Assistance
  • 24/7 Employee Assistance Program
  • Work-life balance supportive culture with hybrid and remote roles
  • 12 Paid Holidays
  • Volunteering and charitable donation match programs
  • Parental Leave and Adoption Assistance
  • On-Site Child Daycare, Café, Fitness Center**
  • Diversity & Inclusion Programs including Colleague Affinity Networks
  • Free virtual live and on-demand wellness classes
  • Competitive salaries, annual bonus and 401(k)* with company match
  • Comprehensive Medical, Dental, Visions coverage effective on start date
  • 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.

Olympus requires all US new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.


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) || Minnesota (US-MN) || Brooklyn Park ||