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Senior Quality Engineer, Calibration - 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

Together we can make a difference

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope – just to name a few.

A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.

Job Function Summary:

This position will oversee all aspects of the calibration program for both production and non-released equipment.

Job Functions:

  • Manages a team of 2-3 employees.
  • Maintains calibration procedures to ensure compliance to external standards and regulations and internal procedures.
  • Provides guidance to Engineering teams on establishing calibration tolerances and ranges based on process requirements.
  • Ensures equipment calibrations are scheduled and completed on time and in accordance with procedure.
  • Works with Planning and Supplier Quality Engineering to address issues with calibration vendors and to maintain vendor contract agreements.
  • Ensures calibration work orders are reviewed and filled appropriately.
  • Addresses any late, missed or out-of-tolerances calibrations are appropriately document and resolved.
  • Appropriately documents and resolves all late, missed or out-of-tolerances calibrations.
  • Serves as the metrology subject matter expert for internal and external audits.
  • Supports all CAPAs, Nonconformances (NCRs) and other projects related to calibration or requiring metrology expertise.
  • Presents data on the calibration program to executive management on a monthly basis and as needed.
  • Completes other assigned tasks as needed.

Required Knowledge, Skills and Abilities:

  • Strong interpersonal, organizational, time management and communication skills.
  • Excellent quantitative and analytical skills.
  • Demonstrated ability to organize, and multi-task, handling a number of projects simultaneously, in a fast-paced environment. 
  • Knowledge of Microsoft Office Products, such as Outlook, Word, Excel and PowerPoint is required.
  • Knowledge of 21 CFR Part 820 and ISO 13485 is required.
  • Knowledge of ISO 10012 and ISO 17025 is preferable.
  • Experience with Equipment Assessment Management software is preferred.

Minimum Requirements:

  • BS in a STEM (Science, Technology, Engineering, Mathematics) field or a related area.
  • A minimum of three years’ previous work experience in calibration in a regulated industry, preferably medical devices.
  • Management experience is preferred.

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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We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world’s most desired medtech company.