Staff Quality Engineer - Lifecycle Quality & Improvements

Regulatory Jobs; Maryland; Sur place; USD 118 000 - 189 000; Plein temps

Avantages offerts par ce poste

Health & Well-being

401(k) & financial planning

Paid time off

Résumé du poste

Waters Corporation seeks a senior Quality Engineer to uphold regulatory compliance and drive quality systems in a high-volume, regulated setting at Sparks, MD. The role emphasizes SOP development, CAPA, and cross-functional quality leadership within engineering projects.

You will mentor the Quality team, leverage Six Sigma and ISO 13485/FDA knowledge, and collaborate with manufacturing to ensure compliant, timely product releases.

Qualifications

• Root cause analysis and CAPA implementation experience.
• Ability to manage multiple tasks and lead projects.
• Lead quality function for engineering projects with reliability concepts and validation planning.
• Clear communication across varied settings and presentations.
• Use of Six Sigma, risk assessment, and statistical tools.

Responsabilités

• Interpret Quality System requirements and develop SOPs and policies.
• Support instrument manufacturing quality systems and lifecycle activities.
• Lead major quality initiatives and report status to leadership.
• Audit readiness and regulatory/compliance activities.
• Mentor the Quality team and share best practices across functions.
• Identify issues delaying products or projects and recommend actions.

Connaissances

Quality Engineering

CAPA

Root Cause Analysis

Six Sigma

Regulatory Knowledge

Project Management

FDA 21 CFR 820

Formation

Bachelor's degree

Master's degree

Description du poste

Waters Corporation seeks a senior Quality Engineer to uphold regulatory compliance and drive quality systems in a high-volume, regulated setting at Sparks, MD. The role emphasizes SOP development, CAPA, and cross-functional quality leadership within engineering projects.

You will mentor the Quality team, leverage Six Sigma and ISO 13485/FDA knowledge, and collaborate with manufacturing to ensure compliant, timely product releases.