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Production Quality Engineer I, Defined Term - Mahwah, NJ

Job Description

Position Overview:

Partner with Production Engineers, in ensuring compliance to FDA, ISO and other medical device regulations. Reviews current procedures and work instructions to determine compliance by ensuring clarity, accuracy, proper sequencing, and manufacturability.

Job Details:

  • Conducts assessments of compliance gaps to current standards and regulations.
  • Coordinates technical activities regarding validations: including protocol development, synchronization of interdepartmental activities, evaluation and reporting results.
  • Reviews and approves product/process qualification/validation and other change control related documentation.
  • Investigates product issues by conducting failure investigations, complaint trending, and Product Inquiries.
  • Investigates component issues by conducting failure/root cause investigations.
  • Communicates, interacts and coordinates quality improvement efforts with Manufacturing, QA, R&D, and engineering management regarding product status, deviations and problems; provides testing and training support to Manufacturing, Engineering and R&D.
  • 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.
  • Reviews and approves product/process qualification/validation and other change control related documentation.

Background Experience:

  • This position requires a Bachelor’s degree in Manufacturing/Industrial, Mechanical, or Biomedical Engineering.
  • One to two 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 processes, manufacturing process support, and process development.
  • 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 be knowledgeable of the application of mathematics.
  • Must demonstrate effective verbal and written communication.
  • Must demonstrate sound judgment, be well organized, take initiative, and be flexible.
  • Previous working knowledge of SAP or equivalent system is highly desirable

This is a “Defined Term” assignment that will last approximately 12 months or until project is complete.  Defined Term employees are eligible for most benefits (including health insurance and paid time off) while on assignment.

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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Job Snapshot

Employment Type Full-Time
Job Type Engineering
Education Not Specified
Experience Not Specified
Manages Others Not Specified
Industry Healthcare - Health Services
Required Travel Not Specified
Job ID 15844
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Production Quality Engineer I, Defined Term - Mahwah, NJ


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