Quality Engineer in Woburn, MA at Tecomet

Date Posted: 12/4/2019

Job Snapshot

Job Description

JOB SUMMARY: 

The Quality Engineer interacts with the Tecomet team to ensure compliance and internal and external customer requirements are met.

ESSENTIAL FUNCTIONS:

  • Maintaining applicable quality system, environmental, and FDA requirements/certifications.
  • Facilitate operator owned quality program
  • Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.
  • Prepare FMEA’s, controls plans, quality plans, PPAP
  • Coordinate process validations and reduce dependence on inspection.
  • Generating applicable quality metric reports; cost of quality, management by facts.
  • Supporting the MRB and RMA processes.
  • Investigate customer complaints including associated actions including CAPA, deviations, and complaint responses.
  • Special projects as assigned by the Director of Quality.

TECHNICAL SKILLS:

  • Metrology
  • Blue Print / GDT
  • Manufacturing Operations
  • FDA / ISO Regulations

EXPERIENCE & EDUCATION:

  • Minimum Associates Degree and 3 plus years of experience in a quality related field or equivalent combination of education and experience.  
  • Bachelors’ degree with engineering focus preferred.
  • Medical Device Manufacturing, ISO 13485, CAPA, Validations and customer interaction experience required.
  • ASQ Certification Preferred           

WORKING CONDITIONS / PYSICAL ABILITIES:

  • Well lighted, heated/or air-conditioned indoor office/production setting with adequate ventilation.
  • Light physical activity performing non-strenuous daily activities of a primarily administrative nature.
  • Ability to occasionally lift and/or move up to 10 pounds.
  • Ability to maneuver throughout the facility/facilities as needed.
  • Manual dexterity sufficient to reach/handle items and work with fingers.
  • Ability to wear proper PPE

TRAVEL REQUIREMENTS:    

  • Can be expected to travel to customers, suppliers etc. as needed

Tecomet is an EOE Employer M/W/Vets/Disabled.