Quality Engineer II – Regulated QMS & CAPA Expert

RXinsider LTD.; Sparks Corner (MD); On-site; USD 85,000 - 120,000; Full time

Job summary

Waters hires a Quality Engineering II to support the Quality Management System, ensure regulatory compliance, and improve product quality in a regulated life sciences environment.

Responsibilities include leading CAPA activities, documenting procedures, and supporting audits while collaborating with R&D, Manufacturing, and Regulatory Affairs to embed quality by design across the lifecycle.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 3-5 years of experience in a Quality Engineering role within a regulated industry (e.g., medical devices, pharmaceuticals, biotechnology).
• Strong understanding of Quality Management Systems (QMS) principles and practical application.
• Demonstrated experience with root cause analysis methodologies (e.g., 5 Whys, Fishbone diagrams) and CAPA implementation.
• Familiarity with statistical process control (SPC) and other quality improvement tools.
• Excellent written and verbal communication skills, with the ability to effectively present technical information.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to work independently and as part of a team in a fast-paced environment.
• Knowledge of ISO 13485 and FDA 21 CFR Part 820 regulations is highly preferred.
• ASQ certification (e.g., CQE) is a plus.

Responsibilities

• Lead and participate in investigations of non-conformances, deviations, and out-of-specification results, identifying root causes and implementing effective corrective and preventive actions (CAPA).
• Develop, review, and approve quality documentation including procedures, specifications, and test methods.
• Support validation activities for equipment, processes, and software, including protocol and report generation and execution oversight.
• Perform risk assessments and develop mitigation strategies to ensure product quality and patient safety.
• Contribute to internal and external audit programs, including participation in audit preparation, execution, and follow-up activities.
• Analyze quality data and trends to identify areas for improvement and propose solutions.
• Collaborate with cross-functional teams (e.g., R&D, Manufacturing, Regulatory Affairs) to integrate quality by design principles throughout the product lifecycle.
• Provide training and mentorship on quality principles and procedures to junior staff members.
• Ensure adherence to cGMP, ISO 13485, FDA, and other applicable regulatory standards.

Skills

Root cause analysis

CAPA

QMS

SPC

Regulatory knowledge

Microsoft Office

Communication

ISO 13485

FDA 21 CFR 820

ASQ CQE (bonus)

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

Microsoft Office

Statistical tools

Job description

Waters hires a Quality Engineering II to support the Quality Management System, ensure regulatory compliance, and improve product quality in a regulated life sciences environment.

Responsibilities include leading CAPA activities, documenting procedures, and supporting audits while collaborating with R&D, Manufacturing, and Regulatory Affairs to embed quality by design across the lifecycle.