Engineer Quality I, Complaints (Wayne, NJ)

Getinge • Wayne, NJ

3d • $85,000 - $90,000

About The Position

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.

Requirements

• 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

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level