Complaints Investigator (Temporary)

Getinge•Wayne, NJ

3d•$33 - $33•Onsite

About The Position

This position will own and provide support and assistance in the investigation of complaints received for products manufactured by Datascope Corp. The position will be responsible for evaluation of complaint complaints, risk analysis, labeling reviews in accordance with the applicable departmental procedures and regulatory requirements. This position will interact with R&D Engineering, Sustaining Engineering and medical reviewers to assist and support complaint investigations. Position will report to Manager, Complaints Engineering, Datascope Corp. The contract term is for 9 months. The position is onsite at the Wayne, NJ Getinge Headquarters., 4 days a week.

Requirements

Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related technical discipline, or an equivalent combination of education and relevant experience.
Minimum of 1 year relevant experience which can include internship or co-op experience in the medical device, pharmaceutical, or regulated industry.
Strong problem-solving skills and a passion for investigation and root cause analysis.
Excellent written and verbal communication skills.
Ability to work in a regulated environment and follow structured procedures.
Detail-oriented with strong documentation and organizational skills.
Proficient in Microsoft Office Suite (Excel, Word, Outlook).Required Knowledge, Skills, and Abilities.
Internal contacts/relationships with all levels of the organization

Responsibilities

Perform engineering investigations of returned products and complaints from the field to determine potential root cause(s) (80%): 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.
Document investigation results clearly and accurately in complaint records in accordance with FDA 21 CFR Part 820, ISO 13485, and other relevant standards (15%)
Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory, Customer Service) to analyze complaint data, trends, and failure modes (5%): The review will include details received from the field for a complaint and the associated investigation activities performed.