Abiomed
Quality Inspector
Job#: 295220
Positions: 1
Posted: 12/06/2016
Job Type: Full Time
Location: Danvers, MA
Department: Global Manufacturing Engineering
Salary: Commensurate with Experience
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Job Description

The Quality Inspector will perform inspections, checks, tests, review of quality documents such as a device history report and sampling procedures of incoming materials, parts/components, partially assembled or finished medical devices. Provide support as needed to the Operations group.

 

Primary Duties and Responsibilities:

 

  • Perform inspections of purchased parts, subassemblies or finished company product according to well-defined criteria using standard physical, mechanical, and/or electrical measurements 
  • Accurately document the results of inspections and testing 
  • Conduct and document process and system audits using written procedures as audit standards 
  • Maintain all controlled document files and test records in a timely and accurate manner 
  • Coordinate calibration of all test equipment and fixtures 
  • Perform data entry into associated data systems. SAP knowledge preferred
  • Monitor critical equipment and instrumentation to ensure proper operation and calibration. 
  • Participate in the construction and/or revision of SOPs for the inspection function 
  • Participates in construction and/or revising inspection procedures, protocols, and checklists 
  • Evaluate problems and make initial recommendations for possible corrective action to the supervisor

 





Skills/Requirements
  • High School graduate or equivalent required. AS in a technical field preferred 
  • 4 years experience in quality inspection. Medical device experience preferred.
  • Extensive knowledge in Geometric Dimensioning & Tolerance preferred
  • Extensive knowledge in IPC – 610 preferred
  • Ability to use all inspection gages and electrical test equipment
  • Knowledge in ISO and GMP. US FDA 21 CFR QSR and ISO 13485 preferred
  • Attention to detail with the ability to follow SOPs inspection procedures
  • Strong ability to perform complex mechanical inspection (may assist engineering with problem solving, fixture design and setups)
  • Strong math and verbal/written communication skills
  • Knowledge of lean, six sigma, kaizen, and continuous improvement initiatives a plus.
  • Ability to Execute tasks in a timely manner under general supervision.
  • Computer literacy required, Working knowledge of Microsoft Office Suite, MRP system; SAP knowledge desired

 

ABIOMED is an Equal Employment Opportunity/Affirmative Action employer.  We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, veteran status, disability or national origin.

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