What are the responsibilities and job description for the Quality Engineer/Senior Quality Engineer position at BioTalent?
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.
- 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).
Qualifications :
