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Quality/Complaints Specialist (Intake Calls/Medical Device)
Medical & Science
We are looking to hire a Quality Complaints Specialist (Medical Device/FDA/Complaints) for a global Q&R group in Andover, MA. Please email your resume to Todd.Schecter@AdeccoNA.com for review.
Responsible to take assigned complaint investigations from evaluation to closure in accordance with internal and external (FDA, Canadian and European) regulatory requirements.
Investigates customer complaints related to product quality and patient safety
Identify potential safety problems.
Investigate complex clinical and technical issues.
Utilizing product knowledge, reproduce a reported problem and if necessary get the appropriate product specialist or Engineer involved to resolve the problem or provide root cause.
. Complete investigations in a timely manner.
Present data in a clear and concise manner in accordance with Standard Operating Procedures into the complaint record.
Prepares responses to customers and field as necessary per process.
Additionally, the Quality Specialist will:
Analyzes and trends Complaint data monthly to identify new and/or systemic issues as necessary.
Presents trend data at monthly quality review meetings
Requires strong written, oral and interpersonal skills to be able to effectively interface interdepartmentally.
Plans, organizes, and priorities own work routine to meet established schedule and support the activities of Q&R.
Proficient computer skills in Microsoft Office
3 years experience investigating device malfunctions and customer problems
Previous experience in a medical device company
Previous experience with FDA medical device regulations, safety standards and regulatory compliance guidelines.
Complaint handling, reporting and trending experience
College degree preferred, but not required
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