QC Coordinator

 

 

With a passion for life

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

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

 

 

Job Overview

 

This position is responsible for various aspects of Quality Control.

 

Job Responsibilities and Essential Duties

 

• Review Device History Records (DHRs) and data collection sheets for IAB Pumps and Spare Parts to ensure completeness, accuracy, and compliance with approved procedures and specifications.
• Verify that all manufacturing, inspection, testing, checklist and documentation requirements have been completed and properly recorded.
• Verify that all QC, inspection, testing, checklist and documentation requirements have been completed and properly recorded
• Ensure GDP (Good Documentation Practices) compliance, including review of entries for accuracy, legibility, traceability, corrections, signatures, and dates.
• Identify and resolve documentation discrepancies, errors, or missing information before product release.
• Coordinate with Manufacturing, Quality, and other cross-functional teams to obtain clarification or corrections as needed.
• Confirm that all quality requirements, acceptance criteria, and supporting records are met before release authorization for materials.
• Authorize the release of materials, IAB Pumps, and Spare Parts upon successful completion of DHR review and verification of all release requirements.
• Ensure timely processing of DHR reviews to support production and shipment schedules.
• Provide guidance, training, and day-to-day support to QC Inspectors to promote consistency and compliance across the department.
• Serve as a quality resource for inspectors, answering questions related to procedures, and documentation requirements.
• Subject non-conforming material into NCMR
• This Job Description is not all-inclusive of responsibilities

 

Minimum Requirements

 

• 3 years of experience in Quality, Manufacturing, Documentation Review, or Quality Assurance within a regulated environment.
• Experience reviewing Device History Records (DHRs), batch records, or manufacturing documentation.
• Experience with Good Documentation Practices (GDP) in medical devices, pharmaceutical, or other regulated industries preferred.
• Experience with product release activities and quality system requirements is highly desirable.

 

Required Knowledge, Skills, and Abilities

 

• DHR Review Experience
• Reads, comprehends, and follows job instructions and/or protocols direction including verbal, written and other work-related documents
• Must have basic math skills, solid understanding of metric and English systems of measurement and be able to read and comply to part specifications.
• Generate and segregate NCMR’s in TrackWise for non-conforming materials
• Ability to record data and written information in English
• Ability to review a wide variety of DHR and data collection sheets for various product types.
• The ability to use Microsoft Windows and Office products such as Word, Excel , Trackwise, SAPME and SAP or equivalent software applications.
• High School diploma required – some college preferred

 

Physical Work Conditions

 

• Use of computer equipment and other related office accessories/devices to complete assignments
• Required to work extended hours during peak business cycles
• 5 lbs. weight lift
• May be required to wear a lab coat

 

This role is based in Wayne, NJ. The base salary for this position is between $32.00 to $35.00 per hour plus overtime. This role is eligible for participation in our Excellence Incentive Plan