Quality Engineer III

BD; Cockeysville (MD); On-site; USD 96,000 - 153,000; Full time

Benefits offered by this job

On-site collaboration

Competitive compensation

Total Rewards program

Job summary

BD is seeking a Quality Engineer to monitor quality indicators across materials and products in a regulated medical device environment in Hunt Valley, Maryland. You will evaluate CTQ parameters, support QM engineering initiatives, and ensure compliance with ISO 13485, 14971, and FDA 21 CFR 820.

The role requires a bachelor's degree in a scientific field and 3 years of experience in quality engineering or related area, with strong problem-solving skills and experience with Minitab, Six Sigma, and

Qualifications

• Bachelor’s degree in sciences or other relevant technical field.
• 3 years’ experience in Quality Engineering or related field.
• Experience in a medical device, pharmaceutical manufacturing facility, or other relevant manufacturing field.

Responsibilities

• Monitor, analyze, and trend quality indicators for materials and products to drive quality improvements.
• Evaluate CTQ parameters and risk to support informed decision-making and efficient product flow.
• Support QM Engineering initiatives and day-to-day quality engineering activities.
• Partner with Plant Senior Quality Manager to ensure Quality Systems across product lines and Enterprise systems.
• Assist with audits, CAPA coordination, product launches and transfers, and change notifications to maintain compliance.
• Use root cause analysis and quality tools to identify issues and implement corrective actions.
• Develop, execute, and monitor corrective action plans for quality concerns.
• Leverage Enterprise tools to improve regulatory compliance and visibility of quality processes.
• Collaborate across functions to promote continuous improvement and operational excellence.

Skills

Quality Engineering

FDA 21 CFR 820

ISO 13485

ISO 14971

Minitab

Six Sigma

Lean Tools

Root Cause Analysis

Project Management

Communication Skills

Education

Bachelor's degree in sciences or relevant field

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

Responsibilities:

• Monitor, analyze, and trend quality indicators for purchased materials, as well as manufactured and distributed components and products, to drive product quality and performance improvements.
• Evaluate Critical to Quality (CTQ) parameters and risk assessment variables to support informed decision-making, predictable product design, and efficient product flow.
• Serve as a key Quality Management (QM) Engineering resource, supporting both Media QM Engineering initiatives and day-to-day quality engineering activities for assigned products and operational areas.
• Partner closely with the Plant Senior Quality Manager to ensure the consistent implementation and application of Quality Systems across new and existing product lines, as well as Enterprise business systems.
• Support compliance with ISO, FDA, and internal quality requirements through: Internal and external audit participation, Cross-functional team collaboration, Project support and execution, Product launches and transfers, Process improvement initiatives, CAPA coordination and resolution, Product quality notifications, Change notifications, Customer complaint investigations and follow-up
• Utilize root cause analysis methodologies and quality tools to identify issues, drive investigations, and implement effective corrective and preventive actions.
• Develop, execute, and monitor corrective action plans to address quality concerns and drive sustainable improvements.
• Leverage Enterprise tools and systems to ensure regulatory compliance, improve visibility, and streamline quality processes.
• Collaborate across functions to promote continuous improvement, strengthen quality system effectiveness, and support operational excellence.

• Demonstrate the ability to proactively manage multiple priorities, lead key initiatives, and drive the successful execution of organizational change efforts.
• Lead and support process control, supplier quality, and continuous improvement projects focused on enhancing product quality, operational efficiency, and compliance.
• Apply statistical methods and quality tools, including statistical sampling and Statistical Process Control (SPC), to analyze performance, identify trends, and implement data-driven improvements.
• Collaborate with cross-functional teams to identify opportunities for process optimization, problem-solving, and sustainable quality improvements.

Required Qualifications:

• Bachelor’s degree in sciences or other relevant technical fiield
• 3 years’ experience in Quality Engineering or other related field.
• Experience in a medical device, pharmaceutical manufacturing facility, or other relevant manufacturing field.

Knowledge and Skills:

• Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience
• Preferred and additional skills and qualifications
• Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization ISO 13485 and 14971.
• Minitab experience is a plus.
• Familiarity with Six sigma, Lean Tools, root cause analysis, and project management techniques
• Ability to represent functional and operations organization with transparency and lead conflict resolution in wide variety of settings.
• Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems.
  

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?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

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.

To learn more about BD visit https://bd.com/careers.

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.

Required Skills

Optional Skills

.

Primary Work Location

USA MD - Hunt Valley

Additional Locations

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$95,900.00 - $153,400.00 USD Annual