Senior Quality Engineering Leader — Regulatory & Audits

BD; Cockeysville (MD); On-site; USD 150,000 - 239,000; Full time

Job summary

BD in Sparks, MD is seeking a Senior Manager of Quality Engineering to lead Quality Systems and Quality Engineering for Micro Reagents operations. The role ensures FDA QMSR, ISO 13485:2016, and MDSAP compliance while driving continuous improvement and audit readiness.

You will partner with Manufacturing, Engineering, Regulatory Affairs, and Operations to set quality strategies, develop talent, and deliver high-quality, compliant products.

Qualifications

• Bachelor's degree in Engineering, Science, Quality, or related technical field.
• 6-8 years of progressive leadership in Quality Engineering, Quality Systems, or regulatory compliance.
• Experience managing Quality Management Systems within a manufacturing environment.
• Strong knowledge of FDA QMSR, ISO 13485:2016, and MDSAP.

Responsibilities

• Lead Quality Systems and Quality Engineering activities supporting Micro Reagents manufacturing.
• Develop, implement, and maintain Quality Management System procedures, policies, and standards in regulatory alignment.
• Ensure compliance with FDA 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.

Education

Bachelor's degree in Engineering, Science, Quality, or another related technical discipline.

Job description

BD in Sparks, MD is seeking a Senior Manager of Quality Engineering to lead Quality Systems and Quality Engineering for Micro Reagents operations. The role ensures FDA QMSR, ISO 13485:2016, and MDSAP compliance while driving continuous improvement and audit readiness.

You will partner with Manufacturing, Engineering, Regulatory Affairs, and Operations to set quality strategies, develop talent, and deliver high-quality, compliant products.