QA Engineer
Insulet Corporation / Neighborhood Diabetes - Bedford, MA

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Job Description:
Position overview: This position is an integral part of
Insulet’s Quality Department and provides support to the
activities for new product development. Serve as a team
member and makes suggestion during inspection process
evaluation and participates during engineering
development validations to ensure compliance to the
standards and protocols. It requires organization and
attention to detail while working with other Quality
functions and engineers to ensure compliance and the
accomplishment of departmental and company goals.
  • Generate, review and maintain Quality records in
support of Quality System, e.g., training, NCR,
CAPA’s and deviations.
  • Assist the QA Engineering staff on new product
development and special projects.
  • Develop an understanding of the new product.
  • Help establish initial FAI methodology on new
product development.
  • Help review component and sub-assembly drawings for
completeness and dimensional measurability.
  • Assist with evaluation of new component inspection
measurement fixtures and GR&R’s.
  • Follow-up with suppliers as required during new
product development qualifications.
  • Perform simple tolerance stack-up analyses.
  • Communicate any quality-related problems to the QA
Engineering management; assist with closure of the
problem and remedial and corrective actions.
  • Assist with and write Test Protocols and Reports.
  • Maintain the CAPA Matrix summary for Complaint Lab
  • Train new employees to summarize complaint
investigations and Root Cause Analysis and drive
further action, when requested.
  • Team reference for certain Pilgrim interface issues.
  • Able to accomplish multiple assignments
  • Assist in gathering information during FDA and ISO
13485 inspections.
  • Other duties as assigned.
Knowledge / Education
  • AS degree in a technical field, or equivalent work
Job Experience
  • Minimum of 3 years in a regulated industry (Medical
Device Industry preferred).
  • Minimum of 3 years in a Quality of manufacturing
related function working with QSR and/or ISO 13485.
  • Basic knowledge of some fundamental using statistics
Skills / Competencies
  • Effective verbal and excellent technical writing
  • Ability to communicate and work effectively within
multiple levels of the organization.
  • Ability to organize and follow through with tasks -
sometimes with minimal supervision
  • Excels at generating and maintaining organized and
accurate records.
  • Pilgrim Software, MS Office, strong word processing
and spreadsheet skills.
Division/Department : Insulet Corporation