Senior Quality Engineering Leader – Compliance & Audits

bdx; Sparks Corner (MD); On-site; USD 150,000 - 239,000; Full time

Job summary

BD, headquartered in the USA, is seeking a Senior Manager of Quality Engineering in Sparks, MD. This role leads Quality Systems and CAPA, ensuring FDA QMSR, ISO 13485, and MDSAP compliance while guiding cross-functional teams and driving continuous improvement in manufacturing operations.

You will mentor quality professionals, manage budgets, and partner with manufacturing, engineering, regulatory, and operations to achieve robust quality and compliance outcomes.

Qualifications

• Bachelor's degree in Engineering, Science, Quality or related technical discipline.
• 6–8 years of progressive leadership experience in Quality Engineering, Quality Systems, Regulatory Compliance, or a related function within a regulated industry.
• Experience managing Quality Management Systems within a manufacturing environment.
• Experience leading quality teams and driving organizational objectives through influence and collaboration.

Responsibilities

• Lead Quality Systems and Quality Engineering activities supporting the Micro Reagents manufacturing operations.
• Develop, implement, and maintain Quality Management System (QMS) procedures, policies, and standards in compliance with regulatory and corporate requirements.
• Ensure compliance with FDA Quality Management System Regulation (QMSR), ISO 13485:2016, MDSAP, and other applicable regulations and standards.
• Provide interpretation and guidance on company-wide quality policies and procedures.
• Maintain appropriate quality oversight of all Quality Management System processes to support a continuous state of compliance.
• Support and strengthen site audit readiness through proactive quality system management and monitoring.
• Lead and support internal, external, customer, corporate, and regulatory audits and inspections.
• Ensure effective execution and continuous improvement of CAPA processes.
• Partner with cross-functional teams to address quality and compliance risks and implement sustainable solutions.
• Support new product development and product enhancement activities by providing quality engineering guidance and oversight.

Skills

Quality Systems

Regulatory Compliance

Leadership

Budgeting

Quality Engineering

FDA QMSR

ISO 13485

MDSAP

Process Improvement

Communication

Talent Development

Education

Bachelor's degree in Engineering, Science

Job description

BD, headquartered in the USA, is seeking a Senior Manager of Quality Engineering in Sparks, MD. This role leads Quality Systems and CAPA, ensuring FDA QMSR, ISO 13485, and MDSAP compliance while guiding cross-functional teams and driving continuous improvement in manufacturing operations.

You will mentor quality professionals, manage budgets, and partner with manufacturing, engineering, regulatory, and operations to achieve robust quality and compliance outcomes.