Senior Advanced Quality Engineer

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Kayseri, Kayseri, 38, Türkiye
Job details
Work flexiblity: Hybrid or Onsite Req ID: R523825 Employee type: Full Time Job category: Engineering Travel: 10% Relocation: No

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Job description

  • *** Please Submit all CV's in English as Fluency in English is a requirement**

    Job Summary

    Lead Quality Engineering activities in the development of products to ensure the highest level of product and process quality. Provide guidance to the New Product Development teams to ensure compliance to the company's quality system and external standards.

    This is an individual contributor role that requires the use of a combination of engineering fundamentals and critical thinking in applying professional expertise and is expected to work independently with minimal supervision.

  • Job Description and Position Summary

    Responsible for quality system support for R&D projects; provide inputs to R&D designs from a quality perspective; work closely with R&D to establish requirements and develop verification and validation strategies for product designs, as well as analyze the risk associated with these designs; provide statistical support and analysis; improve quality processes as they apply to new/existing product design. Works with minimum supervision for performing their duties.

    Essential Duties & Responsibilities

    • Prepare and conduct design reviews by identifying risks associated with the product in scope and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the product development process.
    • Help guide R&D through our internal quality system to ensure products are developed in compliance to those procedures as well as the requirements of the FDA, ISO, and other regulatory bodies.
    • Review and evaluate project documentation for compliance as well as sound technical competence to ensure we are delivering robust products/processes.
    • Establish safety, durability, craftsmanship, and reliability design input specifications based on predicate device quality reports, design reviews, risk analyses, customer research and VOC activities.
    • Support the definition of design verification and validation test requirements that ensure appropriate statistical rationale and objective evidence is available to support the acceptance criteria.
    • Provide input throughout the new product development process from a quality perspective.
    • Perform risk analysis and develop mitigation strategies, and partner with R&D to identify design output solutions that satisfy the product requirements.
    • Collaborate with Design engineers to develop robust verification test strategies to ensure safe, reliable products are implemented.
    • Educate R&D on the use of risk management tools, statistical methods, design and process control activities, and sound verification and validation test planning to help drive quality upfront in new product development.
    • Perform component qualitification activities surrounding PPAP
    • Develop, create and update, as appropriate, procedures for incoming, in-process, and final inspections for new/existing product development
    • Conduct internal Quality system audits and be involved with CAPA projects.
    • Conduct training on Risk Management and QA topics.
    • Develop and establish usability scripts and protocols for formative and summative evaluation, as well as new product development plans and documentation relative to design validation.
    • Analyze and define critical quality attributes for product and process through risk analysis
    • Support Advanced Operations in the development of manufacturing processes for new products.
    • Coach and mentor other quality engineers in quality, R&D and Operations Quality

    Education & Special Trainings

    • ​B.S. Degree in science or engineering required.
    • M.S. on Science or engineering preferred.
    • Six Sigma Green or Black belt preferred.

    Qualifications & Experience

    • Fluency in English is required
    • 2 years relevant industry experience required.
    • Understanding of FDA, ISO 13485, and ISO 14971 and other regulations and standards preferred.
    • Competent with Microsoft Office (Outlook, Excel, Word, etc.)
    • Must possess excellent oral and written communication skills
    • Ability to solve problems in a high stress situation
    • Eagerness to assist internal and external customers
    • Manage projects in a timely manner
    • Ability to conduct and document technical investigation
    • Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
    • Demonstrated ability to effectively work globally and cross-functionally with other departments, including: Advanced Operations, Product Development, Regulatory Affairs, and Marketing.
    • Strong in critical thinking and "outside the box" thinking.
    • Demonstrated ability to advocate for product excellence and quality.
    • Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) preferred.

    Physical Requirements

    • Sedentary work: May be required to move equipment up to 50 pounds, reach, push, or pull in order to accomplish job accountabilities. Generally involved sitting most of the time.
    • Coordination of eye, hand and foot movement with an ability to grasp by hand and meet cognitive demands to include visual and auditory discrimination / memory, reading ability and memory retention ability.
    • Requires use of safety glasses in designated areas.
    • Closed-toe shoes must be worn on the production floor; safety shoes are recommended

    Mental Requirements

    • ​Exercise discretion and independence when applying professional expertise.
    • Must be able to manage time, projects, stress and conflict.
    • Must possess strong interpersonal skills including written and oral communication.
    • Must be able to bring tasks through to completion with minimal supervision.
    • Must have the ability to prioritize work and keep detailed and confidential records.
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