Lead Design Controls & Development Quality Engineer

Abbott; Pleasanton (CA); On-site; USD 114,000 - 228,000; Full time

Job summary

Abbott, a global healthcare leader, seeks an experienced Quality Engineer to independently lead project teams and support Design/Development Quality. You will guide design controls, risk management (FMEA and product risk analysis), and verification/validation activities for new products, ensuring compliance with FDA and global regulations.

In this role, you will mentor engineers, coordinate cross-functional teams, and drive best practices in quality systems, with an emphasis on robust process

Qualifications

• Bachelor's degree required; 9+ years in a related field.
• Expert in quality systems and across functions; broad knowledge of technical options.

Responsibilities

• Provide technical and quality system guidance related to establishing design controls requirements.
• Develop strategy and lead delivery of team or organization deliverables; mentor on technical skill.
• Support design verification and validation for new products; review protocols and reports.
• Lead meetings to prioritize and approve actions addressing issues in problem resolution systems.
• Perform risk evaluation and management activities including FMEA and risk analysis.
• Serve as SME for statistical techniques; support sampling and test activities.
• Participate in reviews to ensure design plans and outputs meet requirements.
• Support process validation; prepare/assist with protocols and reports.
• Possibly support product software development with cross-functional team.
• Drive best practices for establishing requirements and design verification/validation relative to user needs.
• Comply with US FDA regulations and other regulatory requirements.

Skills

FMEA

Product risk analysis

Regulatory compliance

Statistical methods

Education

Bachelor's Degree

Master's Degree

Job description

Abbott, a global healthcare leader, seeks an experienced Quality Engineer to independently lead project teams and support Design/Development Quality. You will guide design controls, risk management (FMEA and product risk analysis), and verification/validation activities for new products, ensuring compliance with FDA and global regulations.

In this role, you will mentor engineers, coordinate cross-functional teams, and drive best practices in quality systems, with an emphasis on robust process