Senior Quality Engineering Leader — Regulated MedTech

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

Benefits offered by this job

Total Rewards program

Job summary

BD is seeking a Senior Manager of Quality Engineering to provide strategic leadership for Quality Systems and Quality Engineering in Sparks, MD. The role ensures compliance with FDA QMSR, ISO 13485:2016, and MDSAP while driving continuous improvement and audit readiness across the organization.

As a member of the leadership team, you will partner with Manufacturing, Engineering, Regulatory Affairs, and Operations to set quality strategies, develop talent, and maintain a culture of quality and

Qualifications

• Bachelor's degree in Engineering, Science, Quality, 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.
• Strong knowledge of FDA Quality Management System Regulation (QMSR), ISO 13485:2016, and MDSAP requirements.
• Ability to lead multiple priorities and execute strategic and operational objectives.

Responsibilities

• Lead Quality Systems and Quality Engineering activities supporting the Micro Reagents manufacturing operations.
• Develop, implement, and maintain Quality Management System procedures, policies, and standards.
• Ensure compliance with FDA QMSR, ISO 13485:2016, MDSAP and other applicable regulations and standards.
• Lead internal, external, customer, corporate, and regulatory audits and inspections.

Skills

Quality leadership

Regulatory compliance

Audits

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Science/Quality

Job description

BD is seeking a Senior Manager of Quality Engineering to provide strategic leadership for Quality Systems and Quality Engineering in Sparks, MD. The role ensures compliance with FDA QMSR, ISO 13485:2016, and MDSAP while driving continuous improvement and audit readiness across the organization.

As a member of the leadership team, you will partner with Manufacturing, Engineering, Regulatory Affairs, and Operations to set quality strategies, develop talent, and maintain a culture of quality and