Senior Quality Engineering Leader

BD

Sparks Corner (MD)

On-site

USD 150,000 - 239,000

Full time

44 hours ago

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Job summary

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

The position partners with Manufacturing, Engineering, Regulatory Affairs, and Operations to set quality strategies, develop talent, manage budgets, and maintain a culture of quality and compliance to deliver

Qualifications

Experience with FDA QMSR, ISO 13485:2016, and MDSAP requirements.
Proven ability to lead quality teams and drive objectives through influence and collaboration.
Authorized to work in the US; no sponsorship available.

Responsibilities

Lead Quality Systems and Quality Engineering activities supporting the Micro Reagents manufacturing operations.
Develop, implement, and maintain QMS procedures, policies, and standards.
Ensure compliance with regulatory standards (QMSR, ISO 13485, MDSAP).
Provide interpretation and guidance on quality policies across the organization.
Maintain audit readiness and drive CAPA processes for continuous improvement.
Lead site leadership collaboration to achieve quality objectives and budgets.