Quality Engineer/Senior Quality Engineer - BioTalent : Job Details

*This is a 100% on-site role based in Carlsbad, CA*

We are seeking a detail-oriented and driven Quality Engineer to join our team in Carlsbad, CA. The ideal candidate will have 2-4 years of experience in quality assurance within a manufacturing environment, a strong foundation in engineering principles, and hands-on knowledge of Non-Conformance Material Reporting (NCMR), equipment calibration, and quality improvement processes.

Key Responsibilities:

• Quality Assurance: Develop, implement, and monitor quality control processes to ensure products meet industry standards and customer expectations.
• Non-Conformance Management: Investigate and resolve NCMR issues, including root cause analysis and implementation of corrective/preventive actions.
• Equipment Calibration: Manage and maintain calibration schedules for manufacturing and testing equipment to ensure compliance with regulatory and company standards.
• Documentation & Reporting: Maintain detailed records of quality activities, prepare reports, and support audits to ensure compliance with company policies and industry regulations.
• Process Improvement: Collaborate with cross-functional teams to identify and implement process improvements that enhance product quality and manufacturing efficiency.
• Compliance: Ensure adherence to quality standards such as ISO, or other applicable frameworks.
• Problem-Solving: Troubleshoot production and quality-related issues to minimize downtime and defects.

Qualifications:

• Bachelor's degree in Engineering (e.g., Mechanical, Industrial, or related field).
• 2-4 years of experience in quality assurance, manufacturing, or production environment.
• Detail-oriented with a commitment to quality excellence.
• Knowledge of NCMR processes and tools.
• Proficiency in equipment calibration/preventive maintenance processes and measurement techniques.
• Familiarity with statistical quality control tools and methodologies.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal abilities.
• Familiarity with lean manufacturing principles.
• Knowledge of regulatory requirements relevant to the industry (e.g., FDA, ISO 13485).