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Associate Production Quality Engineer - Merrimack, NH in Merrimack, NH at Getinge

Date Posted: 2/11/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Merrimack, NH
  • Experience:
    Not Specified
  • Date Posted:
    2/11/2019

Job Description

Job Function Summary:

The Associate Production Quality Engineer will support production teams throughout the lifecycle of product.

Job Functions:

  • Evaluates verification and validation protocols and reports to ensure compliance to external standards and internal standards and procedures.
  • Participates in risk management and analysis techniques when facilitating completion of FMEA within a cross-functional team.
  • Supports Material Review Board (MRB) with containment activities and root cause investigations associated with nonconformances (NCR) / deviations.
  • Updates procedures and other documentation through Engineering Change Orders (ECOs) and Development Change Orders (DCOs).
  • Assists with Process Validation and Design Transfer activities.
  • Ensures the use of statistically valid sampling techniques.
  • Develop, install, and provide support for maintenance of control charts on the floor.
  • Remediate legacy products and documentation as required.
  • Contributes to the team effort by accomplishing related tasks as necessary.
  • Participates and leads CAPAs as needed.
  • Responsible for working with Operations to ensure compliance, cleanliness, and safety on the floor.

Required Knowledge, Skills and Abilities:

  • Good analytical and problem solving skills. 
  • High level of attention to detail and accuracy.
  • Strong computer skills, including MS Office applications (Word/Excel) and statistical software are required.
  • Knowledge of Quality Assurance methods, such as process validation, design of experiments, statistical process control (SPC) and protocol/report preparation. 
  • Knowledge of ISO 13485 and FDA requirements.

Minimum Requirements: 

  • Bachelor’s Degree in Engineering or Science, or equivalent work experience.
  • A minimum of one year of Quality Management System (QMS) experience.

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

 

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