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
