Sr Design Quality Engineer

About the role

This position performs various quality engineering functions and owns Quality Assurance/Document Control/Design Control within the scope of their product line. This includes supporting Design Control projects as well as other duties in support of the Quality System, Design Control System, Document Control, Manufacturing, and the R&D/Product Development departments. Additionally, the Senior Quality Engineer functions as a subject-matter resource for interfacing with cross functional partners in Engineering, Operations, and outside suppliers.

Responsibilities

• Serve as the Quality representative on cross-functional project teams, ensuring Design Control principles are effectively applied to product and process changes as well as 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 the development and review of FMEA, FMECA, FTA, and other risk assessment documentation.
• Analyze product and process nonconformances, determine root causes, and drive robust corrective and preventive action (CAPA) plans.
• Perform internal and supplier quality system audits to ensure compliance with regulatory and quality standards.
• 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 closely with manufacturing sites and other division facilities to ensure consistent quality practices and compliance across operations.
• Serve as an independent Quality Assurance reviewer and chair Design Reviews to ensure objective evaluation of product development activities.
• Mentor and develop quality professionals, technicians, and engineers through coaching, knowledge sharing, and technical guidance.
• Provide oversight and supervision for technicians and engineers, supporting performance, development, and project execution.
• Maintain awareness of evolving industry trends, regulations, and best practices through participation in professional organizations and industry forums, and communicate relevant insights to the business.

Required Qualifications

• BS/MS Engineering (BME or EE or 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

Knowledge and Skills

• Detail oriented and ability to organize large amounts of work and data. This includes the need for good documentation practices.
• Regulatory knowledge and experience including but not limited to FDA, MDSAP, PMDA, CFDA
• Demonstrated experience working with international suppliers/manufacturers as it relates to product quality and reliability
• Demonstrated history of successfully interpreting regulations, and procedures
• Demonstrated skill in statistical analysis and applied statistical methodologies

Preferred Qualifications

• ASQ Certification

Additional information

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.