Quality Engineering II

Becton Dickinson NA

Sparks Corner (MD)

On-site

USD 96,000 - 153,000

Full time

9 days ago

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Job summary

BD (Becton, Dickinson, and Company) in Sparks, MD is seeking a Quality Engineering II to develop, implement, and maintain the Quality Management System (QMS) and ensure regulatory compliance in a life sciences manufacturing setting. You will drive quality improvements, CAPA, and risk mitigation across product lifecycles.

The role emphasizes root-cause analysis, CAPA implementation, and cross-functional collaboration with R&D, Manufacturing, and Regulatory Affairs to uphold cGMP, ISO 13485, and

Qualifications

Bachelor's degree in Engineering, Life Sciences, or related field.
3-5 years in Quality Engineering within a regulated industry.
Strong knowledge of QMS principles and CAPA.
Familiarity with SPC and quality tools.
Excellent written and verbal communication skills.

Responsibilities

Lead and participate in investigations of non-conformances, deviations, and out-of-spec results, identifying root causes and implementing 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 prep, execution, and follow-up.
Analyze quality data and trends to identify areas for improvement and propose solutions.
Collaborate with cross-functional teams to integrate quality by design throughout the product lifecycle.
Provide training and mentorship on quality principles and procedures.
Ensure adherence to cGMP, ISO 13485, FDA, and other applicable regulatory standards.

Skills

Root cause analysis

CAPA implementation

QMS principles

ISO 13485 knowledge

FDA 21 CFR Part 820

ASQ CQE

MS Office

Education

Bachelor's degree in Engineering or Life Sciences

Tools

MS Office

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 purposeBD 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.

Work Location and Environment

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, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

At BD, we believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

Equal Opportunity Statement

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.

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