Quality Engineering II

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

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

We Are The People Who Give Possibilities Purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Job Summary

The Quality Engineering II will support the development, implementation, and maintenance of the Quality Management System (QMS) to ensure compliance with regulatory requirements and internal procedures. This role will focus on improving product quality, processes, and overall customer satisfaction within a life sciences manufacturing environment.

Job 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.

Job 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.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD