QA Engineer

Vor 2 Tagen

Munich, Bayern, Deutschland EPM Scientific Vollzeit

Role: Quality Assurance Engineer

Location: Remote Contract: 6 Months

Overview:
We are seeking an experienced
Quality Assurance Engineer
to ensure the highest quality standards in new product development projects for our client. This role involves driving quality across design and manufacturing processes, supporting verification and validation activities, and mitigating risks in product features.

Key Responsibilities

  • Drive Quality in Product Development:

  • Apply best practices in
    Design for Manufacturability (DFM)
    and
    Statistical Process Control (SPC)
    .

  • Oversee
    Design Validation (DVT)
    and
    Process Validation (PVT)
    testing.
  • Define and monitor
    Critical-to-Quality (CTQ)
    characteristics.

  • Documentation & Traceability:

  • Develop and maintain
    traceability matrices
    to ensure all product requirements are met.

  • Ensure accurate and complete documentation for audits and regulatory compliance.

  • Verification & Validation Support:

  • Review and approve
    V&V plans and reports
    .

  • Collaborate with engineering teams to ensure test coverage aligns with risk assessments.

  • Risk Management:

  • Conduct risk assessments for new product features.

  • Prioritize testing efforts based on identified risks and potential impact.

  • Continuous Improvement:

  • Recommend process improvements based on data-driven insights.

  • Support root cause analysis and corrective actions using tools like
    8D Reports
    .

Qualifications

  • Experience:
    Minimum
    5+ years
    in Quality Assurance within product development or manufacturing.
  • Education:
    Degree in
    Engineering
    ,
    Life Sciences
    , or related field.
  • Technical Skills:
  • Proficiency in quality methodologies and tools:
    8D
    ,
    Gage R&R
    ,
    FMEA
    , feasibility studies.
  • Familiarity with standards:
    ISO 9001
    ,
    GxP
    ,
    ISO 31000
    .
  • Certifications:
  • Six Sigma Green Belt or Black Belt
    preferred.
  • Soft Skills:
  • Strong analytical and problem-solving abilities.
  • Excellent communication and stakeholder management skills.

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