Senior Design Controls & Quality Engineer

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

Benefits offered by this job

Free medical coverage

Strong retirement plan

Tuition reimbursement

Education benefits

Global employer

Diversity recognition

Job summary

Abbott in Pleasanton, CA seeks an experienced Quality Engineer to independently or lead a project team across Design/Development Quality. You will manage design controls, risk management and verification/validation activities for new products while ensuring regulatory compliance.

The role emphasizes cross-functional collaboration, mentoring, and process validation support, with opportunities to influence product development in a globally respected healthcare company.

Qualifications

• Bachelor's Degree.
• Minimum 9 years of related work experience with a complete understanding of specified functional area.
• Comprehensive knowledge of a particular technological field.
• Is recognized as an expert in work group and across functions.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Has broad knowledge of various technical alternatives and their potential impact on the business.

Responsibilities

• Provide technical and quality system guidance for design controls.
• Develop strategy and lead delivery of team deliverables; coach on technical skills.
• Support design verification/validation per planning procedures.
• Lead meetings to prioritize and approve actions from issue resolution.
• Perform risk evaluation and management including FMEA and risk mitigation.
• Subject matter expert for statistical techniques; support sampling and analysis.
• Participate in reviews to ensure design plans and deliverables meet requirements.
• Represent QE in design output reviews and approvals.
• Support process validation; prepare protocols and reports.
• May assist product software development with cross-functional team.
• Apply best practices for requirements, verification, validation, user needs.
• Comply with FDA and other regulatory requirements and company policies.
• Maintain collaboration with cross-functional teams, especially R&D.
• Work as an individual contributor and mentor QE team members.

Skills

Design controls

Risk management

FMEA

Statistical methods

Quality system

Regulatory compliance

Education

Bachelor's degree

Master's degree

Job description

Abbott in Pleasanton, CA seeks an experienced Quality Engineer to independently or lead a project team across Design/Development Quality. You will manage design controls, risk management and verification/validation activities for new products while ensuring regulatory compliance.

The role emphasizes cross-functional collaboration, mentoring, and process validation support, with opportunities to influence product development in a globally respected healthcare company.