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Quality Engineer II - 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:

  • Provide guidance to level I Engineers
  • Plan and execute the process and system remediation
  • Conduct assessments of compliance gaps to current standards and regulations
  • Coordinate technical activities regarding validations: including protocol development, synchronization of interdepartmental activities, evaluation and reporting results
  • Review and approve product/process qualitfication/validation and other change control related documentation
  • Investigate product issues by conducting failure/root cause investigations
  • Communicate, interact,a nd coordinate quality improvement efforts with Manufacturing, QA, R&D, and Engineering management regarding product status, deviations and problems; provide testing and training support to Manufacturing, Engineering and R&D
  • Plan, execute and prepare clear and concise written reports of audit or review observations, including an assessment of compliance during internal audits of facility quality systems
  • Support quality management, which includes ensuring that corrictive and preventative actions areissued as required, properly investigated, documented and completed in accordance with the annual audit procedure/schedule
  • Facilitate and consult with corrective action teams in implementing changes to ensure compliance with all applicable QSR/ISO/MDD/CMDR/MDR requirements
  • Perform re-audits and/or effectiveness verifcation as a way of assissing and decumenting CAPA effectiveness
  • Review and approve product/process qualification/validation and other change control related documentation

Required Knowledge, Skills and Abilities

  • Position requires ability to perform statistical analysis as needed. Must be able to work independently and take initiative to hlep drive results in a fast paced work environment.
  • Must demostrate an ability to work effectively in a team setting.
  • Must be knowledgeable of the application of mathematics.
  • Must demonstrate effective verbal and written communication.
  • Must demonstrate sound judgement, be well organized, take initiative, and be flexible.
  • Previous working knowledge of SAP or equivalent system is highly desirable.

Minimum Requirements:

  • Bachelor's degree in Manufacturing/Industrial, Mechanical, Biomedical Engineering or equivalent.
  • 1-2 years in manufacturing and/or process engineering required. Experience in the medical device or other FDA regulated industry is preferred.
  • Previous working knowledge in some of the following areas is required: continuous improvement processes, Kanban equipment design, re-tooling, re-engineering and automation of production prodesses, manufacturing process support, and process development.

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.


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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