Staff Quality Engineer

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.

Salary up to $120,000 annually + bonus