Complaints Investigator (Temporary)

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.

Complaints Investigator (Temp) Wayne, NJ

Job Overview

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.

Job Responsibilities and Essential Duties

• 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 withFDA 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.

Knowledge, background and experience

• 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

The minimum salary for this is position is $33/hour and a max of $33/hour

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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.

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.