onsite
Principal I, Research & Development Quality Assurance - alcon
Software Engineer
Lead R&D quality assurance initiatives, ensuring compliance with GMP, FDA and ISO 13485 standards while driving validation, risk management, and statistical analysis for medical device development.
About the role
Key Responsibilities
- Develop and implement quality assurance strategies for research and development projects, aligning with GMP, FDA and ISO 13485 requirements.
- Lead validation activities, including protocol design, execution, and documentation for processes, equipment, and software.
- Conduct risk assessments and manage mitigation plans to ensure product safety and regulatory compliance.
- Perform statistical analysis of experimental data to support design decisions and quality improvements.
- Collaborate with cross‑functional teams to integrate quality standards into product design, testing, and manufacturing processes.
Requirements
- Bachelor’s or higher degree in Engineering, Life Sciences, or related field with extensive experience in R&D quality assurance.
- Strong knowledge of GMP, FDA regulations, and ISO 13485 standards for medical devices.
- Proven experience in validation, risk management, and statistical data analysis.
- Excellent documentation and audit preparation skills.
- Ability to lead and mentor technical teams in a fast‑paced, innovative environment.
Skills
software developmentsystem designproblem solving