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Quality Operations Engineer

Full time Danaher in Engineering Email Job
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Job Detail

  • Offered Salary 1000
  • Experience 2 Years
  • Gender Male
  • Industry Management
  • Qualifications Degree Bachelor

Job Description

KEY RESPONSIBILITIES

  • Generate, prepare and issue complex data for assigned quality reports.
  • Provide input in Customer Feedback failure investigations.
  • Review change orders and deviations
  • Ensure maintenance of validated state, and consideration for re-validation during various design and process changes.
  • Ensure maintenance of product ID and traceability, including that of safety critical parts.
  • Review and approve the criteria for WIP reworks and re-inspections.
  • Drive improvements in process capability and quality of products.
  • Provide support to process validation and other processes on the manufacturing floor, warehouse and facilities as required.
  • Proactively identify potential problems and drive continuous improvement, utilizing the CAPA/SCAR and other processes.
  • Establish and monitor use of risk assessment tools for project tracking and management.
  • Assure project adherence to Design Controls to deliver robust, manufacturable products which meet the defined delivery timeline, design inputs and quality metrics to meet business unit goals.
  • Identify and drive countermeasures in instances when deviations to the project plan occur.
  • Effectively communicate and maintain visual tools for project tracking and management
  • Effectively employ Danaher Business System (DBS) tools and concepts to maximize efficiency and quality.
  • Works with team members to develop team goals and plans, resolve problems and achieve goals.

Knowledge and skills:

  • Fast learner, and able to quickly become adept at using the Danaher Business System tool set
  • Readily accepts responsibility and accountability for project success and key decisions
  • Experience in the application of production and process controls including process validation, process control plans and statistical process control.
  • Experience in risk management process (sFMEA, pFMEAs, dFMEAs etc.).
  • Communication skills, both oral and written.
  • Ability to work effectively in a team environment and build strong working relationships.
  • Foster an environment that values diversity and inclusion.
  • High degree of initiative and self-motivation.
  • Strong analytical and problem-solving skills.

TRAINING RESPONSIBILITIES:

  • Complete all assigned and required training satisfactorily and on time

REQUIREMENTS

  • Bachelor’s degree in technical field desired with 2+ years of related work experience OR
  • Master’s degree in technical field desired with 0-2 years of related work experience

PREFERRED QUALIFICATIONS:

  • Experience in the medical device industry, knowledge of CFR 21 Part 820 (QSR), ISO 13485.
  • Quality engineering certification from the American Society for Quality (ASQ), or other qualifying organizations. Examples may include but not limited to the CQE, CRE, CQA, etc

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