Staff Design Quality Engineer, Hardware

$121,100 - $199,800/Yr

BD - San Diego, CA

Full-time - Mid Level

San Diego, CA

5,001-10,000 employees

Miscellaneous Manufacturing

About the position

The Staff Quality Engineer is a pivotal member of the New Product Development Team at BD, a leading global medical technology company. This role is integral to ensuring that quality engineering principles are effectively applied throughout the entire product development lifecycle, from initial research to product launch. The Staff Quality Engineer is responsible for overseeing QA-related research and development activities, ensuring that all quality aspects are meticulously managed and aligned with regulatory standards. This position emphasizes the importance of collaboration and communication within cross-functional teams to drive product quality and compliance. In this role, the Staff Quality Engineer will act as the core team quality representative for design control projects, which includes both new product development and sustaining engineering efforts. The responsibilities encompass managing quality planning, verification and validation processes, risk management, and providing regulatory compliance support. The engineer will work closely with Program Managers to ensure that design deliverables meet the necessary standards for limited commercial and general release. Additionally, the role involves collaborating with Quality Engineers to verify design specifications and requirements effectively. The Staff Quality Engineer will also lead continuous improvement initiatives, actively participate in product requirement development, conduct product system hazard analyses, and facilitate design reviews. A significant aspect of the role includes leading or supporting Corrective and Preventive Action (CAPA) investigations and ensuring that product technical files and Design History Files are complete and auditable. Compliance with Quality System Regulations, ISO, and FDA requirements is paramount, and the engineer will support internal and external audits, product launches, and process improvements while coordinating the resolution of CAPAs and customer complaints. This position requires a proactive approach to engaging with partners to drive consensus and resolve issues promptly. The Staff Quality Engineer will provide statistical support and analytical problem-solving expertise for product-related challenges, serving as a resource for less experienced colleagues.

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 and execution, risk management, and regulatory compliance support.
• Provide clarification and guidance to teams on the overall quality system with an emphasis on design controls.
• Collaborate closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release.
• Work with Quality Engineers to ensure effective verification of design specifications and requirements.
• Drive continuous improvement efforts by facilitating, leading, and collaborating with cross-functional teams.
• Participate actively in the development of product requirements, product system hazard analysis, and design reviews.
• Lead or support CAPA investigations and ensure CAPA closures.
• Ensure product technical files and Design History Files are complete and auditable.
• Follow Quality System Regulations and established procedures to ensure compliance.
• Support internal and external audits, product launches, and process improvements, and coordinate the resolution of CAPAs, product quality notifications, change notifications, and customer complaints.
• Proactively engage partners to drive consensus and resolve issues in a timely manner.
• Provide statistical support and expertise and analytical problem-solving for product-related challenges.
• Act as a resource for colleagues with less experience.

Requirements

• Bachelor's degree in science, engineering, or a relevant subject area.
• Minimum of 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 excellent 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.
• Knowledge of lean tools and techniques (Practical Problem Solving, A3, PFMEA, and/or Fishbone diagrams).
• Familiarity with GMP and regulatory requirements for medical devices.
• Experience with hardware development within a regulated environment is preferred.
• Thorough understanding of risk management and quality by design is preferred.
• Experience in production and process control is preferred.
• Quality Engineering Certification (ASQ) or equivalent is preferred.
• Experience in Project/Program Management is preferred.

Nice-to-haves

• Experience in Project/Program Management is preferred.
• Quality Engineering Certification (ASQ) or equivalent is preferred.

Benefits

• Competitive salary package
• Comprehensive health insurance
• 401(k) retirement plan
• Paid time off and holidays
• Professional development opportunities
• Employee recognition programs
• Flexible work arrangements
• Wellness programs