Job Details

Job Summary:

We are seeking a motivated Engineer II, Quality to support quality operations for instrument manufacturing at Becton Dickinson's Irvine facility. This role is responsible for ensuring compliance with cGMP, FDA regulations, and internal quality standards while supporting investigations, documentation, and continuous improvement initiatives.

Key Responsibilities:

• Review and assess Quality Notifications, Complaints, Deviations, and Waivers for assigned product lines.
• Conduct and support complaint investigations and assist in resolving manufacturing and quality issues.
• Ensure compliance with cGMP, FDA regulations, ISO standards, and internal quality procedures.
• Oversee operations to ensure accurate documentation, adherence to procedures, and timely updates.
• Provide technical input and data analysis to support quality improvements and project initiatives
• Collaborate cross-functionally with manufacturing, engineering, and quality teams.
• Utilize statistical methods and tools to analyze data and support decision-making.
• Participate in continuous improvement efforts and support audits/inspections as needed.

Required Qualifications:

• Bachelor's degree (BS/BA) in Engineering (Mechanical, Electrical, Industrial), Biological Sciences, Chemistry, Computer Science, or related field with 2+ years of experience
• OR Master's degree with no prior experience required.
• Working knowledge of Quality Systems Regulations (QSR), cGMP, ISO, and FDA guidelines
• Experience with complaint handling, deviations, and quality investigations
• Familiarity with statistical analysis and quality tools/software
• Proficiency in Microsoft Office Suite and ability to learn new systems.

Preferred Qualifications:

• Project management experience.
• Professional certifications such as CQA, CQE, SQE, CQM, Six Sigma, or similar.
• Experience in medical device or pharmaceutical manufacturing environments