Staff Design Quality Engineer, Hardware

$121,100 - $199,800/Yr

BD - San Diego, CA

Full-time - Mid Level

San Diego, CA

Miscellaneous Manufacturing

About the position

The Staff Quality Engineer plays a crucial role in the New Product Development Team, overseeing quality assurance-related research and development activities from inception to product launch. This position is responsible for applying quality engineering principles to both new product development and sustaining engineering projects, ensuring compliance with regulatory standards and driving continuous improvement efforts.

Responsibilities

• Serve as the core team quality representative for design control projects, including new product development and sustaining efforts.
• Manage all quality aspects of the design control process, including quality planning, verification and validation planning and execution, risk management, and regulatory compliance support.
• Provide guidance to teams on the overall quality system with a focus on design controls.
• Collaborate with Program Managers to ensure design deliverables are met for limited and general release.
• Work with Quality Engineers to verify design specifications and requirements effectively.
• Facilitate and lead continuous improvement efforts with cross-functional teams.
• Participate in the development of product requirements, hazard analysis, and design reviews.
• Lead or support CAPA investigations and ensure timely closure of CAPAs.
• Ensure completeness and auditability of product technical files and Design History Files.
• Support compliance with ISO and FDA requirements through audits, project support, and process improvements.

Requirements

• Bachelor's degree in science, engineering, or a relevant subject area.
• Minimum of 8 years of experience in R&D development, Quality Engineering, and Design Control.
• Proficient in Microsoft Office Suite (Excel, Word, PowerPoint).
• Excellent verbal and written communication skills.
• Strong attention to detail and organizational skills.
• Ability to work independently and as part of a team.
• Experience with root cause analysis tools and corrective action plans.
• Knowledge of quality systems and regulatory standards, including 21 CFR 820, ISO 13485, and ISO 14971.
• Familiarity with GMP and regulatory requirements for medical devices.

Nice-to-haves

• Experience with hardware development in a regulated environment.
• Thorough understanding of risk management and quality by design principles.
• Experience in production and process control.
• Quality Engineering Certification (ASQ) or equivalent.
• Experience in Project/Program Management.

Benefits

• Competitive salary range of $121,100.00 - $199,800.00 USD annually.
• Opportunities for professional development and learning.
• Comprehensive health insurance coverage.
• 401k retirement savings plan with matching contributions.
• Paid time off and holidays.
• Employee discounts on products and services.