What are the responsibilities and job description for the Senior QA Engineer - 253581 position at Medix™?
Responsibilities
- Develop, review, and maintain inspection procedures and quality documentation.
- Lead and manage nonconformance investigations (NCs) and CAPA activities through resolution and effectiveness verification.
- Partner cross-functionally with Engineering, Manufacturing, and Quality teams to support IQ/OQ/PQ validation activities and process qualifications.
- Provide operational quality support throughout the product lifecycle, including audits, change control, and manufacturing readiness initiatives.
- Support root cause investigations and drive continuous improvement efforts using quality tools and data analysis.
Qualifications
- Experience working within ISO 13485 and 21 CFR 820 regulated medical device environments.
- Strong understanding of Quality Management Systems (QMS) and regulatory compliance requirements.
- Hands-on experience with risk management activities and methodologies, including ISO 14971 exposure.
- Proven background managing NCs, CAPAs, and root cause analysis investigations.
- Ability to collaborate effectively across cross-functional teams in manufacturing and quality settings.
Salary : $100,000 - $125,000