Staff Quality Engineer, Hardware (Dispensing)

$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 is a pivotal member of the New Product Development Team at BD, one of the largest global medical technology companies. This role is integral to ensuring that quality engineering principles are effectively applied throughout the new product development process and sustaining engineering projects. The Staff Quality Engineer is responsible for overseeing QA-related research and development activities from the initial research phase through to product launch. This position requires a deep understanding of quality systems and regulatory standards, as well as the ability to manage all quality aspects of the design control process, including quality planning, verification and validation planning, risk management, and regulatory compliance support. In this role, the Staff Quality Engineer will act as the core team quality representative for design control projects, ensuring that all design deliverables are met and can be released for limited or general commercial use. The engineer will collaborate closely with Program Managers and Quality Engineers to ensure effective verification of design specifications and requirements. Additionally, the Staff Quality Engineer will drive continuous improvement efforts by facilitating and collaborating with cross-functional teams, actively participating in product requirement development, product system hazard analysis, and design reviews. The position also involves leading or supporting Corrective and Preventive Action (CAPA) investigations and closures, ensuring that product technical files and Design History Files are complete and auditable. Compliance with ISO and FDA requirements is critical, and the Staff Quality Engineer will support internal and external audits, participate in teams, and coordinate the resolution of CAPAs, product quality notifications, change notifications, and customer complaints. The role requires proactive engagement with partners to drive consensus and resolve issues in a timely manner, as well as providing statistical support and analytical problem-solving expertise for product-related challenges. This position also serves as a resource for colleagues with less experience, fostering a collaborative and supportive work environment.

Responsibilities

• Act 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, risk management, and regulatory compliance support.
• Provide clarification and guidance to teams on the overall quality system with an emphasis on design controls.
• Collaborate with Program Managers to ensure design deliverables are met and can be released for limited or general commercial use.
• Work with Quality Engineers to ensure effective verification of design specifications and requirements.
• Drive continuous improvement efforts by facilitating and collaborating with cross-functional teams.
• Participate in the development of product requirements, product system hazard analysis, and design reviews.
• Lead or support CAPA investigations and closures.
• Ensure product technical files and Design History Files are complete and auditable.
• Support compliance with ISO and FDA requirements through internal and external audits, project support, and process improvements.
• Engage proactively with partners to drive consensus and resolve issues in a timely manner.
• Provide statistical support and analytical problem-solving for product-related challenges.
• Act as a resource for colleagues with less experience.

Requirements

• Minimum of a BS degree in science, engineering, or a relevant subject area.
• At least 8 years of experience with an emphasis on 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 with strong organizational skills.
• Ability to work independently as well as part of a team.
• Ability to use root cause analysis tools and execute corrective action plans.
• Knowledge of quality systems and regulatory standards requirements including 21 CFR 820, ISO 13485, ISO 14971.
• Familiarity with GMP and regulatory requirements for medical devices.

Nice-to-haves

• Experience with hardware development within 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 from $121,100.00 to $199,800.00 USD annually.
• Opportunities for professional development and career growth.
• Comprehensive health insurance coverage.
• Retirement savings plan options.
• Paid time off and holidays.
• Employee recognition programs.