Quality Engineer II

Job Title: Quality Engineer II

Location: San Diego, CA

Duration: 06 Months

Job Summary:

The Quality Engineer II will develop and maintain quality engineering methodologies and provide quality engineering support across new product development, manufacturing, and quality system activities.

Key Responsibilities:

• Develop and implement effective process control systems for product development, qualification, and manufacturing.
• Lead quality assurance, process control, and CAPA activities to meet internal and regulatory requirements.
• Identify, investigate, and resolve quality issues using structured problem-solving methodologies.
• Design and execute experiments for process optimization and continuous improvement.
• Develop experiment protocols, plans, reports, and supporting documentation.
• Monitor and control Critical-to-Quality (CTQ) parameters and specifications.
• Apply Lean Manufacturing and Six Sigma methodologies to improve product and process performance.
• Lead investigations and corrective actions related to product and process nonconformances.
• Participate in cross-functional teams and provide Quality Engineering support for projects and product development.
• Complete and maintain product and process risk assessments.
• Support product verification and validation activities in collaboration with Design Engineering.
• Work with Microbiology teams to support environmental monitoring and microbiological requirements.
• Support Quality Management System (QMS), Environmental Management System (EMS), and other applicable regulatory requirements.
• Ensure compliance with FDA, GMP, ISO 13485, ISO 14971, and applicable quality and regulatory standards.

Qualifications:

• Bachelor's degree in Engineering, Technical field, or equivalent combination of education and experience.
• Master's degree preferred.
• 2 5 years of Quality Engineering or related engineering experience.
• Experience with quality tools, methodologies, and process improvement techniques.
• Working knowledge of FDA regulations, GMP, ISO 13485, and ISO 14971.
• Experience with CAPA, nonconformance investigations, process controls, and risk management.
• Experience with Lean Manufacturing and Six Sigma methodologies.
• Strong statistical and data analysis skills.
• Strong technical documentation and report-writing skills.
• Excellent verbal and written communication skills.
• Strong project management, leadership, organizational, and problem-solving abilities.
• Ability to work effectively in cross-functional teams and a fast-paced environment.
• Strong attention to detail with the ability to manage multiple priorities and meet deadlines.
• Medical device industry experience preferred.
• ASQ CQE or related quality certification preferred.