Engineer Quality I, Complaints (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

The Complaint Engineer I conducts complaint investigations to identify causes of reported product defects. The role analyzes complaint data to detect undesirable trends and performs escalation request to drive effective corrective actions. It collaborates cross functionally to support timely resolution of product issues and support corrective and preventive actions.

Job Responsibilities and Essential Duties

• Perform complaint investigations to determine potential cause(s). This includes evaluating field-reported information, reviewing applicable risk assessments, instructions for use (IFU), trend data, and other relevant documentation. The primary goal is to determine possible failure mechanisms and contributing factors related to the reported issue
• Initiate, own and support Corrective and/or Preventive Actions
• Perform daily, weekly, monthly data analysis of complaints to identify adverse trends
• This is not an inclusive list of job responsibilities

Required Knowledge, Skills and Abilities

• Bachelor's degree in biomedical engineering, Mechanical Engineering, Electrical Engineering, or related technical discipline.
• Minimum of 1 year experience in complaint handling and complaint investigations for medical devices.
• General understanding of Good Manufacturing Practices, good Documentation Practices FDA regulations, and ISO requirements.
• Experience with Complaint, Corrective and Preventive Actions, Field Actions processes.
• Experienced with handling Biohazard materials.

• Experience with laboratory work in the medical devices industry.
• Proficient in Microsoft Office Suite (Power Bi, Excel, Word, Outlook)
• Excellent written and verbal communication skills.
• Strong problem-solving skills and a passion for investigation and root cause analysis
• Strong interpersonal skills.
• Good organizational skills. Must be able to adhere to timelines.
• Basic understanding of statistical analysis.
• Basic understanding of quality systems

The base salary for the position is a minimum salary of 85,000 and a maximum of 90,000, plus 8% 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.