QA Engineer

EPM Scientific; München; Remote; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading medical equipment company is seeking a Quality Assurance Engineer for a remote 6-month contract. The successful candidate will drive quality in product development using methodologies such as Design for Manufacturability (DFM) and Statistical Process Control (SPC). This role demands 5+ years of experience in Quality Assurance and familiarity with ISO standards. Ideal candidates will possess strong analytical skills and a Six Sigma certification. Join an innovative team to ensure product excellence in the medical field.

Qualifikationen

• Minimum 5+ years in Quality Assurance within product development or manufacturing.
• Familiarity with ISO standards such as ISO 9001 and ISO 31000.
• Certifications: Six Sigma Green Belt or Black Belt preferred.

Aufgaben

• Drive quality in product development using DFM and SPC.
• Develop documentation for audits and regulatory compliance.
• Conduct risk assessments for new product features.

Kenntnisse

Quality methodologies and tools

Statistical Process Control (SPC)

Design for Manufacturability (DFM)

Analytical problem-solving

Stakeholder management

Ausbildung

Degree in Engineering, Life Sciences, or related field

Tools

8D Reports

FMEA

Gage R&R

Jobbeschreibung

Quality Assurance Engineer – Remote, 6‑month contract.

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.

Seniority Level

Not Applicable

Employment Type

Contract

Job Function

Quality Assurance

Industries

Medical Equipment Manufacturing