Quality Engineer II (Wayne, NJ)

GetingeWayne, New Jersey, United States

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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

A Bachelor's degree in Engineering, Science or related field or equivalent is required. A Master of Science in Engineering, Science or related field is preferred. CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) is desirable.

A minimum of 3 years' experience in quality assurance, quality engineering or related functions or a M.S. plus 1 year experience is required. Prior experience in a FDA regulated industry or ISO certified organization.

Must have demonstrated proficiency in statistical analysis, the ability to analyze and solve complex problems, and the ability to communicate effectively across departments.

Working knowledge of quality systems is required. Familiarity with analytical software applications is preferred.

Project management and leadership experience is preferred. Previous experience supervising technicians and conducting and participating in FDA / customer / corporate audits is preferred.

Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.

Ability to use Microsoft Office Products such as Word and Excel or equivalent software applications is preferred.

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.

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Quality Engineer Ii • Wayne, New Jersey, United States