Document Control Specialist - Wayne, United States - Getinge

Getinge
Getinge
Verified Company
Wayne, United States

1 week ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Document Control Specialist

Wayne, NJ

At Getinge we have the passion to perform
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally.

At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows.

Every day we collaborate to make a true difference for our customers - and to save more lives.

Are you looking for an inspiring career? You just found it.


To assist and provide guidance to documentation owners to meet requirements of the Cardiac Assist quality management system required for Getinge's customer and regulatory requirements.

This role will assist owners in the implementation of documentation through the local Quality Management System ensuring adherence to good documentation principles.


The qualified applicants will be responsible for the following:

  • Review Change Notices (CNs), Protocols/Protocol Results/RFDs, Part Number Requests etc. for correctness and completion in accordance with the Cardiac Assist Quality Management System.
  • Support the completion of tasks as needed such as adding additional approval routings, uploading files, updating the Originator (per request) as well as other tasks.
  • Assist as needed in the Creation, maintenance, and implementation of Part Numbers, Change Notices, and other activities required in SAP (ERP system) to maintain and ensure compliance between Documentation system and SAP.
  • Proofreads and completes a final review of the documents within the Quality Management System, prior to Release/Implementation (verifies effectivity date(s), proper GDP etc.).
  • Implements/Releases CNs, Protocols/Protocol, Results/RFDs etc., if applicable
  • Assist in completing data entry for routing creation and changes to current routings, material master, and bill of materials (BOM) in SAP, when required.
  • Provides overall support and guidance to Documentation users by providing guidance on the Part Number Request and Change Request processes.
  • Troubleshoots QMS system issues, and provides answers to general questions relating to QMS and SAP in cooperation with the IT department.
  • Manages workflow, including business needs and priorities daily, creates finished good documents and material numbers, as needed.
  • When needed, facilitate the creation and processing of Change Notices on behalf of users who cannot access the system.
  • Trains new users and communicates enhancements to user community, when notified.
  • Provide various KPI and metric data as directed by Manager.
  • Completes all required training per established procedures.
  • Executes data reconciliation in SAP and resolves issues as they occur, as required.
  • Provides solutions to non IT issues involving Document Control processes.
  • Participates and supports regulatory agency audits and inspections as a Backroom Resource.
  • Instructs the engineering staff on the creation of parts, BOMs and routings.
  • Participates and assists in the creation, revision and process improvements of Document Control SOP's and processes.
  • Contributes to the Quality Assurance department as needed including document control support for Cardiac Assist
  • Bachelor's Degree or equivalent in a related field or relevant work experience in a related function is required.
  • 23 years previous experience in Windchill required
  • Experience in medical device or regulatory environment is preferred.

Salary Range:
$85k-$95k

Remote Work: 1-2 Days

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

  • Health, Dental, and Vision insurance benefits
  • 401k plan with company match
  • Paid Time Off
  • Wellness initiative & Health Assistance Resources
  • Life Insurance
  • Health and Dependent Care Flexible Spending Accounts
  • Commuter Benefits
  • Parental and Caregiver Leave
  • Tuition Reimbursement


Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future.

Our passionate people hold our brand promise 'Passion for Life' close to heart.
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Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. _


INDLG

Pay:
$85, $95,000.00 per year


Work Location:
In person
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