Senior Quality Engineering Leader — Regulatory & Compliance

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

Job summary

BD, a global leader in medical technology, seeks a Senior Manager of Quality Engineering in Sparks, MD to lead QMS and quality systems across Micro Reagents manufacturing. The role partners with engineering, operations, and regulatory to advance compliance and operational excellence.

Ideal candidate has 6–8 years in quality leadership within regulated manufacturing, with strong FDA/ISO knowledge and budget management.

Qualifications

• Bachelor's degree in Engineering, Science, or another related technical discipline.
• Minimum of 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.
• Experience managing departmental budgets, work plans, and performance goals.
• Strong knowledge of FDA Quality Management System Regulation (QMSR), ISO 13485:2016, and MDSAP requirements.
• Strong understanding of Quality Management Systems, quality engineering principles, and regulatory compliance.
• Proven ability to lead multiple priorities and execute strategic and operational objectives.
• Strong verbal and written communication skills with the ability to communicate effectively at all levels of the organization.
• Ability to build relationships, influence stakeholders, and drive results in a matrixed environment.
• Applicants must be authorized to work for ANY employer in the US.

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 QMSR, ISO 13485:2016, MDSAP.
• Provide interpretation and guidance on company-wide quality policies and procedures.
• Maintain appropriate quality oversight of all QMS processes for continuous compliance.
• Support site audit readiness through proactive quality system management.

Skills

Quality systems

Regulatory compliance

Quality engineering

Leadership

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Science

Job description

BD, a global leader in medical technology, seeks a Senior Manager of Quality Engineering in Sparks, MD to lead QMS and quality systems across Micro Reagents manufacturing. The role partners with engineering, operations, and regulatory to advance compliance and operational excellence.

Ideal candidate has 6–8 years in quality leadership within regulated manufacturing, with strong FDA/ISO knowledge and budget management.