Staff Quality Engineer

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

A leading life science and medical device manufacturing client in Hunt Valley, Maryland is looking to hire top talent to their quality engineering team!

Responsibilities

• Serve as a highly visible Quality professional responsible for interpreting and applying Quality System requirements and developing, maintaining, and implementing Standard Operating Procedures (SOPs) and organizational policies within a regulated manufacturing environment.
• Make key decisions and recommendations supporting critical organizational objectives.
• Support regulated diagnostic and/or medical-device products throughout the product life cycle, including manufacturing, distribution, and post-market activities.
• Lead major Quality System and business initiatives, including serving as a project manager and communicating project status to leadership.
• Provide expert guidance across core Quality System elements, including process control and supplier qualification, while identifying and driving continuous improvement opportunities.
• Apply statistical tools and data-analysis techniques to identify trends and root causes, drive corrective actions, and resolve moderately complex quality issues.
• Support internal and external audit activities, ensuring organizational readiness and compliance with applicable requirements.
• Apply advanced quality engineering principles, technical concepts, and quality-science methodologies to deliver measurable and validated results.
• Provide training and mentorship to Quality team members and offer cross-functional guidance on Quality principles, policies, and best practices.
• Identify issues that could delay products or projects and recommend appropriate actions to mitigate risk and maintain timelines.
• Ensure documentation and quality processes comply with applicable regulatory and quality standards.

Required Qualifications

• 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.

Knowledge and Skills

• Demonstrated success in root-cause determination and effective CAPA implementation.
• Ability to manage multiple priorities and lead successful, timely execution of complex projects.
• Experience leading or influencing Quality activities for engineering projects, including reliability engineering, validation planning and execution, and continuous improvement initiatives.
• Proficiency with statistical sampling, Six Sigma root-cause analysis methodologies, risk assessment, failure analysis, and project-management techniques.
• Strong analytical and problem-solving skills with the ability to gather, interpret, and communicate critical information.
• Excellent communication skills with the ability to clearly present technical perspectives in one-on-one discussions, team meetings, and formal presentations.
• Ability to drive results and effectively manage conflict within cross-functional teams.
• Working knowledge of applicable medical-device Quality System and regulatory requirements, including FDA 21 CFR Part 820 and ISO 13485:2016.