Quality Engineer II - Exempt

Join our team as a Quality Engineer in the vibrant city of Menlo Park, CA, where innovation meets opportunity. This role offers the chance to work in a dynamic environment focused on the production of Class III pharma products.

Must Have Skills

• Process validation
• NCMR (Non-Conformance Material Reports)
• CAPA (Corrective and Preventive Actions)
• Risk Management
• Problem Solving
• Six Sigma
• 5-Why Analysis
• Continuous Improvement

Responsibilities

• Support production by resolving technical issues through NCMR and/or CAPA.
• Implement process improvements and update work instructions.
• Support operators, inspectors, and technicians in the production and inspection of components, sub-assemblies, and finished goods.
• Develop, modify, apply, and maintain quality standards and protocols.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Devise and implement methods and procedures for inspecting, testing, and evaluating precision and accuracy.
• Conduct quality assurance tests and perform statistical analysis.
• Ensure corrective measures meet acceptable reliability standards and compliance requirements.

Education and Experience Required

• Bachelor’s degree in an engineering field.
• Minimum 2 years of experience in a Class II or above medical device company.

Work Schedule and Location

This is a 100% onsite role at 1555 Adams Drive, Menlo Park, CA 94025, working 40 hours per week.

Additional Information

• Work independently with general supervision on larger, moderately complex projects.
• Contribute to the completion of project milestones and may have involvement in cross-functional assignments.
• Communicate primarily with internal contacts to share information, gain input, and support decision-making.
• May provide guidance to entry-level professionals.