Product Analyst I - Medical Device Complaints

Job Description: General Summary: Coordinate product returns, and sterilization thereof. Analyze returned products from complaints. Create the written report. Maintain records (hard copy, soft copy, etc) relative to product returns.

Specific Duties and Responsibilities

Analyzes product complaints. Confirms complaint. Determines root causes, when possible.

Interfaces with various internal and external entities such as Manufacturing, R & D, Marketing, or the Paris Vigilance office and Cork to assist with obtaining complete information or product complaint analyses.

Reviews all product specifications, including FG, QS, relevant MPQI, etc. Generate a written report for each product complaint and distributes the results to appropriate recipients

Receives and processes return products. Coordinates, documents, and initiates sterilization process. Archives products.

Reviews SAP for shipping history and other relevant batch information.

Reviews device history records for information that may contribute to root cause analysis.

Complaint trending.

Performs responsibilities required by the Quality System and other duties as assigned or requested.

Fulfills special project requests, such as participating in improvement team projects, historical data analysis, obtaining and correlating information which may contribute to a management decision.

Position Qualifications

Minimum education: High school diploma or equivalent. Preferred 2 years college level coursework or equivalent in Quality, engineering, technical writing, or computer systems.

Minimum experience: At least 2 years experience in mechanical assembly and inspection. Medical device industry experience preferred.

Clear oral and written communication skills.

Working knowledge of word processing, spreadsheet, and database computer applications.

or equivalent combination of education and experience required to perform at this level.

Searchable Keywords: Product Analyst I complaints adverse events field actions clinical regulatory compliance / gj-mo

Minimum Education Required: High School

Years of Experience Required: At Least 1 Year

Expected Travel Time: None


Boston Scientific offers incredible opportunities to grow and advance, a dynamic work environment and an excellent benefits package. Boston Scientific is an equal opportunity employer, M/F/D/V.