Complaint Specialist, Post-Market Surveillance - Newark, United States - GForce Life Sciences

Description

SummaryOur client, a Fortune 500 Medical Device Company, has engaged GForce Life Sciences to provide a complaint specialist. This position will report to a quality manager within the quality department.

Duties / Expectations of RoleAssist team with complaint investigations which can involve risk assessments, complaint history review searches, and escalating to CAPA if necessary.

Will review surgical techniques guides and create customer letters.
Assist with front-end complaint-handling tasks.

Assist with reviewing new complaints for accuracy and setting them up for future processingCompleting diligence tasks to get products returned and updating complaints with any additional information receivedTransacting product returns and scrap while helping with initiation when customer service is short-staffed.

Apply departmental procedures to the evaluation of complaint information for acceptable content and supporting data. Independently evaluate information, reports and data.
Prepare complaint data summaries and trend reports regarding complaints and complaint process key performance indicators. Prepare complaint-related data for Management Review.
Other duties and projects as may be assigned.
Mandatory RequirementsB.S. Degree, preferably in Engineering2+ years of prior complaint-handling experience with a medical device companyQuality experienceNice to HavePrior experience processing medical device complaints or quality assurance/regulatory affairs backgroundPatient care experienceKnowledge of 21 CFR 820 regulations and ISO 13485Decision Tree experience with complaintsProficient with use of complaint and quality-related IT systems and toolsTerm & Start3 monthsASAPFull-time (40 hours/week)Possibility of extensionHybrid (Mon-Wed) in Parsippany, NJBenefits included (Medical, Dental, Vision, 401k)Pay Rate - $30-34/hr#J-18808-Ljbffr