Senior Design Quality Engineer — MedTech Design Controls Lead

Becton, Dickinson and Company (BD); Covington (VA); On-site; USD 90,000 - 130,000; Full time

Job summary

BD is seeking a Senior Quality Engineer to own QA/Document Control/Design Control within a product line, interfacing with engineering, operations, and suppliers. You will lead QA activities, author QA documentation, and drive CAPA and risk management initiatives across design and manufacturing.

You will develop and review DHFs, validation protocols, and quality records while mentoring engineers and collaborating with cross-functional partners to ensure regulatory compliance and continuous

Qualifications

• BS/MS in Engineering (BME/EE/ME).
• 5 years of experience in FDA regulated environment.
• 3 years of product design experience.
• 2 years of Quality Engineering experience in a regulated environment.
• ASQ Certification preferred.
• Detail oriented with strong documentation practices.

Responsibilities

• Serve as the Quality representative on cross-functional project teams, ensuring Design Control principles are applied to product and process changes and new product development activities.
• Provide Quality Assurance leadership and guidance to project teams and within the Quality organization.
• Author, review, and approve Quality System documentation, including CAPAs, audit reports, and related quality records.
• Develop, review, and approve product quality documentation, including Design History Files (DHFs) and other design control deliverables.
• Create, review, and approve validation protocols and reports for products, processes, software, and stability studies.
• Lead and support risk management activities, including development and review of FMEA, FMECA, FTA, and other risk assessment documentation.
• Analyze product and process nonconformances, determine root causes, and drive CAPA plans.
• Perform internal and supplier quality system audits to ensure regulatory and quality standards compliance.
• Review and investigate product complaints, supporting timely resolution and continuous improvement efforts.
• Monitor, track, and trend key quality metrics and indicators to identify risks and improvement opportunities.
• Partner with manufacturing sites to ensure consistent quality practices across operations.
• Serve as independent QA reviewer and chair Design Reviews to ensure objective evaluation of product development activities.
• Mentor and develop quality professionals, technicians, and engineers through coaching and guidance.
• Provide oversight for technicians and engineers, supporting performance and project execution.
• Maintain awareness of evolving industry trends and communicate insights to the business.

Skills

FDA regulated experience

Product design

Quality Engineering

Education

BS/MS Engineering (BME/EE/ME)

Job description

BD is seeking a Senior Quality Engineer to own QA/Document Control/Design Control within a product line, interfacing with engineering, operations, and suppliers. You will lead QA activities, author QA documentation, and drive CAPA and risk management initiatives across design and manufacturing.

You will develop and review DHFs, validation protocols, and quality records while mentoring engineers and collaborating with cross-functional partners to ensure regulatory compliance and continuous