What are the responsibilities and job description for the Senior Quality Engineer position at SOHO Square Solutions?
Responsibilities:
- Support production line transfers and ensure compliance with quality standards
- Lead component qualification and test method validation
- Collaborate with cross-functional teams to find creative, compliant solutions
- Support product launch & initial manufacturing operations
- Maintain and update documentation per internal Quality Policies & FDA/GMP guidelines
- Conduct failure analysis and assist in resolving manufacturing issues during process development
- Provide data-driven input on technical issues and projects
Qualifications:
- Experience: 3–10 years in medical device or pharmaceutical industry (regulated environment required)
- Education: BS/BA in Chemical, Biochemical, Mechanical, Electrical, Industrial Engineering, Biological Sciences, Chemistry, or related field
- Regulatory Knowledge: Working understanding of GMP, ISO, FDA Quality Systems Regulations
- Technical Skills: PFMEAcreation, Component qualification activities, Test method development & validation, Failure analysis & root cause investigation, Statistical methods & software (Minitab, JMP, etc.)