Job Title: QA Specialist - Complaint Handling
Location: Boston, MA
Zip Code: 02113

Description:

Main Responsibilities

Documentation and maintenance of the complaint program
Co-ordinate investigations of customer complaints and prepare reports of investigations.
Track and trend complaint rates
Review the inspection and disposition of returned goods as part of an RGA program
Documentation and maintenance of the CAPA program
Working with document control to maintain training and lot release program
Participate and assist during ISO, FDA and internal audits
Supporting product sterilization, environmental and bioburden program
Manage the Company's compliance with its internal biological and particulate testing programs, ensure that product samples are forwarded to the Company's contract laboratories and that on-site testing is scheduled and conducted on a timely basis.
Manage the environmental monitoring on a quarterly basis
General administrative support on department projects

Minimum Requirements:

Bachelor's Degree from a 4 year college or university (preferred but not required)
2+ years relevant experience
Strong written and verbal communication skills
Detail oriented with exceptional organization skills
Database and word processing
Ability to work with others to achieve goals and objectives.

Supplemental Requirements:

Working knowledge of QSR, CMDCAS and ISO 13485
Experience with industry related software packages (InfoMed/Relsys)
Independent & self motivated with good time management skills
Flexibility & adaptability to change
Professionally interact with all levels of company personnel, vendors and customers

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