Lead Development Quality Engineer

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

Job summary

Abbott in Pleasanton, CA is seeking a senior quality/validation professional to lead design controls and development quality efforts. Independently or with a project team, you will plan and execute risk-based quality programs, coordinate with R&D and manufacturing, and ensure compliance with FDA regulations.

You will review protocols, reports, and validation plans, drive verification and validation activities, perform FMEA and risk analyses, and mentor QE staff.

Qualifications

• Bachelor’s Degree (required).
• Minimum 9 years of related work experience with a complete understanding of the functional area.
• Comprehensive knowledge of a technological field.
• In-depth knowledge of business unit functions and cross-group dependencies.
• Recognized expert within work group and across functions.
• Experience in a quality system environment.
• Awareness of governmental regulations and compliance requirements.
• Ability to solve complex problems with analytical evaluation.

Responsibilities

• Independently or lead a project team to support Design/Development Quality.
• Provide guidance on establishing design controls requirements and strategy.
• Lead execution of deliverables and mentor on technical skills.
• Support design verification and validation activities for new products and review protocols/reports.
• Lead meetings to prioritize and approve action plans addressing issues.
• Perform risk evaluation and management (FMEA, risk analysis).
• Serve as SME for statistical techniques and support sampling/analysis activities.
• Participate in reviews to ensure design plans and outputs are met.
• Represent QE in review/approval of design outputs and validation protocols.
• Support process validation activities and cross-functional collaboration.
• Ensure compliance with FDA regulations and company policies.

Education

Bachelor’s Degree

Master’s Degree

Job description

Abbott in Pleasanton, CA is seeking a senior quality/validation professional to lead design controls and development quality efforts. Independently or with a project team, you will plan and execute risk-based quality programs, coordinate with R&D and manufacturing, and ensure compliance with FDA regulations.

You will review protocols, reports, and validation plans, drive verification and validation activities, perform FMEA and risk analyses, and mentor QE staff.