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Quality Engineer I - Fairfield, NJ

Getinge AB Deutschland

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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 Functions: (Primary "essential” duties and responsibilities)

  • Conducts assessments of compliance gaps to current standards and regulations.
  • Investigates compliance issues by conducting failure/root cause investigations.
  • Plans, executes and prepares clear and concise written reports of audit or review observations, including an assessment of compliance during internal audits of facility quality systems.
  • Supports Quality management, which includes ensuring that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time, and that audits are properly performed, documented, and completed in accordance with the annual audit procedure/schedule.
  • Facilitates and consults with corrective action teams in implementing changes to ensure compliance with all applicable QSR/ISO/MDD/CMDR/MDR requirements.
  • Performs re-audits and/or effectiveness verifications as a way of assessing and documenting CAPA Effectiveness.
  • Assists in the review of external standards and corporate procedures to ensure compliance by updating internal documentation as needed.
  • Support quality initiatives for improvements to Quality processes, Quality testing, and other areas as identified.
  • May assist during Internal Audits, Third Party Audits (e.g. ISO, FDA, etc.) as requested.
  • Supports technical activities regarding validations: including protocol development, synchronization of interdepartmental activities, evaluation and reporting results.
  • May support gathering of data for monthly and quarterly meetings.

Education Requirement

  • BS degree, Manufacturing/Industrial, Mechanical, Biomedical Engineering or equivalent.
  • 1-2 years in manufacturing and/or process engineering field required. Experience in the medical device or other FDA regulated industry is preferred.

Required Knowledge, Skills and Abilities:

  • Position requires ability to perform statistical analysis as needed. Must be able to work independently and take initiative to help drive results in a fast paced work environment.
  • Must demonstrate an ability to work effectively in a team setting.
  • Must demonstrate effective verbal and written communication.
  • Must demonstrate sound judgment, be well organized, take initiative, and be flexible.

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.

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