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Quality Assurance Product Analyst

vor 3 Monaten


Köln, Nordrhein-Westfalen, Deutschland SciPro Vollzeit

Position Overview:

SciPro is looking for a meticulous and knowledgeable Product Specialist with a strong background in auditing products that utilize software, as well as those produced through metal and plastic fabrication methods. The ideal candidate will play a crucial role in assessing and auditing these products to guarantee adherence to regulatory standards and the company's quality benchmarks.

Core Responsibilities:

  • Perform thorough evaluations of products that integrate software, emphasizing their capacity to manage, monitor, or affect the functionality of active or implantable devices.
  • Assess the production methods for items crafted from metal and plastic, ensuring compliance with industry regulations and internal protocols.
  • Design and execute audit strategies that tackle potential risks and compliance challenges associated with software-driven and manufactured products.
  • Work closely with interdisciplinary teams, including engineering, production, and quality control, to pinpoint improvement opportunities and ensure that audit results are acted upon.
  • Generate comprehensive audit documentation that details findings, corrective measures, and suggestions for enhancing processes.
  • Remain informed about regulatory guidelines and industry best practices concerning software-integrated products and manufacturing methodologies.
  • Offer training and support to internal teams on compliance and quality expectations related to software integration and material production.
  • Assist in external regulatory assessments by preparing necessary documentation and representing the organization in discussions about product compliance.

Required Qualifications:

  • Bachelor's or Master's degree in Engineering, Quality Assurance, or a related discipline.
  • Demonstrated experience in product auditing, quality control, or regulatory compliance.
  • In-depth knowledge of software-integrated products, including embedded systems and control software.
  • Familiarity with metal and plastic production processes and methodologies.
  • Exceptional analytical abilities and attention to detail.
  • Strong communication and report-writing capabilities.
  • Ability to collaborate effectively with cross-functional teams.
  • Understanding of applicable regulatory standards (e.g., ISO, FDA) and quality management frameworks.
  • Certifications in auditing (e.g., CQA, CQE) are advantageous.