QC Coordinator

About Us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing, and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

About the Role

This position is responsible for various aspects of Quality Control, ensuring completeness, accuracy, and compliance with approved procedures and specifications for IAB Pumps and Spare Parts.

Responsibilities

• 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.
• 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.

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.
• High School diploma required – some college preferred.

Skills

• DHR Review Experience: Reads, comprehends, and follows job instructions and/or protocols, including verbal, written, and other work-related documents.
• Basic math skills, solid understanding of metric and English systems of measurement, and ability to read and comply with part specifications.
• Generate and segregate NCMRs 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.
• Proficiency in Microsoft Windows and Office products such as Word, Excel, TrackWise, SAPME, and SAP or equivalent software applications.

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.

Pay

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 (EIP), an annual incentive program that rewards performance against financial and operational goals.

Benefits

• 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.