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Sr. Quality Inspector 1st Shift

Date:  Nov 24, 2022
Location: 

Danvers, Massachusetts, US, 01923

Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, and offices in Baltimore, MD, Woburn, MA, Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 2,000 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.

 

Patients First | Innovation | Winning Culture | Heart Recovery
 

The Sr. 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.

 

Principle Duties and Responsibilities:

 

  • Perform inspections of purchased parts, subassemblies or finished company product according to criteria using standard visual, physical, mechanical, and/or electrical measurements
  • Ability to perform visual inspection on large lots of complex components under a microscope.
  • Perform mechanical inspection using advanced inspection systems which included using a vision and or touch probe system
  • Accurately document inspection and testing results to record components acceptance or rejection
  • 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 department 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. 
  • Participates in construction and/or revising inspection procedures, protocols, and checklists 
  • Assist engineers in developing or improving inspection processes and check list as problems or opportunities are identified
  • Identify and evaluate problems and make initial recommendations for possible corrective action to the supervisor

 

Job Qualifications:

  • High School graduate or equivalent required. Associate Degree in a technical field a plus
  • 5 plus years experience in quality inspection. Medical device experience preferred.
  • Strong ability to perform complex mechanical inspection (may assist engineering with problem solving, fixture design, setups and quality plans)
  • Perform mechanical inspection using advanced systems which includes using vision and touch probe
  • Perform electrical and optical cable and sensor testing
  • Extensive knowledge in Geometric Dimensioning & Tolerance
  • Extensive knowledge in IPC – 610
  • Ability to use all inspection gages, electrical test equipment and microscope
  • Knowledge in ISO and GMP. US FDA 21 CFR QSR and ISO 13485
  • Attention to detail with the ability to follow SOPs inspection procedures
  • Strong math and verbal/written communication skills
  • Knowledge of lean, six sigma, kaizen, and continuous improvement initiatives
  • Ability to execute tasks in a timely manner with minimal supervision
  • Ability to drive and adapt to changing business needs and department priorities
  • Proficient in SAP desired and knowledge of Microsoft Office

 

 

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.


Nearest Major Market: Boston