Senior Quality Engineer, Medical Devices & Compliance

Cypress HCM; Sparks Corner (MD); Presencial; USD 110.000 - 150.000; Jornada completa

Descripción de la vacante

Cypress HCM in Hunt Valley, Maryland is seeking a senior Quality Engineer to ensure compliance with Quality System requirements across the product lifecycle of medical devices. The role emphasizes root-cause analysis, CAPA, and collaboration with cross-functional teams to drive continuous improvement.

The ideal candidate will bring extensive experience in regulated environments, strong analytical skills, and proven ability to lead complex quality initiatives while ensuring alignment with FDA 21

Formación

• Bachelor's degree with 10 years of experience in a regulated environment, or Master's degree with 5 years of experience in a regulated environment.
• At least 5 years of experience in Quality Engineering.

Responsabilidades

• Interpret and apply Quality System requirements and develop SOPs and policies in a regulated manufacturing environment.
• Lead major Quality System and business initiatives, including serving as a project manager and communicating status to leadership.
• Support regulated diagnostic/medical-device products throughout the product life cycle (manufacturing, distribution, post-market).
• Provide guidance across core Quality System elements, including process control and supplier qualification, driving continuous improvement.
• Apply statistical tools and data-analysis to identify trends, root causes, drive CAPA, and resolve quality issues.
• Support internal and external audit activities and ensure readiness and compliance with regulatory requirements.
• Apply quality engineering principles to deliver measurable and validated results; mentor team members.

Conocimientos

Root-cause analysis

CAPA implementation

Cross-functional leadership

Statistical analysis

Six Sigma

Risk assessment

Project management

Verbal & written communication

Regulatory knowledge

Educación

Bachelor's degree in a regulated environment

Master's degree in a regulated environment

Descripción del empleo

Cypress HCM in Hunt Valley, Maryland is seeking a senior Quality Engineer to ensure compliance with Quality System requirements across the product lifecycle of medical devices. The role emphasizes root-cause analysis, CAPA, and collaboration with cross-functional teams to drive continuous improvement.

The ideal candidate will bring extensive experience in regulated environments, strong analytical skills, and proven ability to lead complex quality initiatives while ensuring alignment with FDA 21