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.

Job Overview

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.

Job Duties

• 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

Minimum Requirements

• Bachelor's Degree or equivalent in a related field or relevant work experience in a related function is required.
• 3 years systems application and process experience required.
• 2-3 years previous experience in Windchill required
• Experience in medical device or regulatory environment is preferred.

Salary range: $85k - $95k

About us

Getinge is on an excitingtransformation journey constantly looking for new ways to innovate together with our customersto meet the healthcare challenges of the future. Our passionatepeople hold our brand promise 'Passion for Life' close to heart.

Ifyoushareourpassionandbelievethatsavinglivesisthegreatestjobinthe world, thenwelook forwardtoreceivingyourapplication and resume. We hope you will join us on our journey to become the world's most respected and trusted MedTec company.

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
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

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.