Quality Engineer II (Wayne, NJ)

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 implementation and execution of Quality Engineering II. This position provides leadership and technical support for the quality assurance, process control, and engineering functions. Leads or is a key contributor to cross functional process improvement and problem-solving teams.

Job Responsibilities and Essential Duties

• Leads Statistical Process Control (SPC) initiatives on EVH manufacturing lines, including data collection, trend analysis, and process capability assessments to ensure product and process stability.
• Supports and coordinates equipment qualifications and process validations (IQ, OQ, PQ, PPQ) by developing and executing protocols, synchronizing interdepartmental activities, and analyzing validation data.
• Performs detailed data analysis to identify process variation, validate sampling plans, and establish appropriate control limits across critical manufacturing and inspection processes.
• Initiates, manages, and audits ship holds to contain potential quality risks, ensuring traceability, communication, and timely resolution in coordination with Quality, Manufacturing, and Distribution teams.
• Maintains and updates distribution lists for containment, data trending, and escalation of quality issues, ensuring accurate cross-functional communication.
• Provides technical and analytical support to the Quality Control laboratories, including review of Device History Records (DHRs), support of validation activities, and updates to product and testing specifications.
• Reviews and approves qualification, validation, and change control documentation in compliance with GMP and ISO 13485 requirements.
• Conducts or supports failure investigations and complaint trending to identify root causes and drive process improvements.
• Supports the Material Review Board (MRB) through evaluation of non-conforming materials and recommendations for disposition.
• Collaborates closely with Manufacturing, Engineering, and R&D to communicate product status, deviations, and improvement opportunities, providing guidance and training as needed

Required Knowledge, Skills, and Abilities

The base salary for this position is a minimum of 87,000 and a maximum of 95,000 plus 8% in annual bonus

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.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.