Senior Quality Engineering Leader – Regulatory Compliance

BD; Glencoe (KY); On-site; USD 150,000 - 239,000; Full time

Job summary

BD in Sparks, MD is seeking a Senior Manager, Quality Engineering to lead Quality Systems and Quality Engineering across the Micro Reagents manufacturing operations. The role ensures compliance with FDA QMSR, ISO 13485, and MDSAP while driving continuous improvement and audit readiness.

The position partners with Manufacturing, Engineering, Regulatory Affairs, and Operations to establish quality strategies, develop talent, and maintain a culture of quality and compliance, advancing operational

Qualifications

• Bachelor’s degree in Engineering, Science, Quality, or another 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.
• Experience managing departmental budgets, work plans, and performance goals.
• Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time.

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.

Skills

Quality Systems

Regulatory Compliance

Leadership

Budget Management

Cross-functional Collaboration

Quality Engineering

Education

Bachelor’s degree in Engineering, Science, Quality, or related technical discipline

Job description

BD in Sparks, MD is seeking a Senior Manager, Quality Engineering to lead Quality Systems and Quality Engineering across the Micro Reagents manufacturing operations. The role ensures compliance with FDA QMSR, ISO 13485, and MDSAP while driving continuous improvement and audit readiness.

The position partners with Manufacturing, Engineering, Regulatory Affairs, and Operations to establish quality strategies, develop talent, and maintain a culture of quality and compliance, advancing operational