Product Complaint Analyst (Medical Device) in Burlington, MA at Volt

Date Posted: 10/9/2019

Job Snapshot

  • Employee Type:
  • Duration:
    24 weeks
  • Date Posted:
  • Job ID:
  • Pay Rate
    $0.0 - $33.34/Hour
  • Contact Name
    Volt Branch
  • Phone

Job Description

Product Complaint Analyst (Medical Device)

Location: Burlington, Massachusetts. 01803


We are seeking a high caliber, team player as Product Surveillance Analyst. The analyst receives, reviews and investigates medical device complaints and maintains quality documents to ensure compliance with various agencies.

In this role, you will:

  • Review and investigate all incoming customer comments related to product quality and patient safety.
  • Oversee the input of information documenting same into the database.
  • Review clinical study data and assesses the need for supplemental reports as new information is received.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Communicate clearly and positively with all levels of employees, customers, contractors, and vendors.

Experience you may have that would be helpful:

  • Complaint handling experience in a closely related field in the medical device and/or pharmaceutical industry or equivalent.
  • Able to work cooperatively and productively with others.
  • EXCELLENT Time Management Skills; Able to meet deadlines on multiple projects.
  • Able to understand & comply FDA regulations & Company operating procedures, processes, policies and rules is essential.
  • Must be able to demonstrate a working proficiency in operating a personal computer and possess the ability to perform basic word processing/spreadsheet tasks using applications such as MS Word and Excel.
  • Must be able to maintain regular and predictable attendance; the ability to work overtime.

Your preferred qualifications and education:

  • Bachelor’s degree in Health/Sciences.  Nursing degree is fine too (ASN/BSN)
    • Knowledge of how the body works, how medical devices work
  • Medical terminology and mechanical circulatory systems knowledge
  • At least 6 months of experience working with customer complaints preferred
  • Knowledge of global regulatory agencies (e.g. FDA, ECA), able to submit reports within required timeframe

Please apply to position or contact Matt Haltom at (317) 599-4898 for any questions and more details regarding this position.

Volt has been serving some of the nation's strongest companies for over 60 years. As a Volt employee, you can expect the highest level of on-site support. We have a long-standing tradition of developing lasting and mutually beneficial relationships with its employees.                        

Volt is an Equal Opportunity Employer