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

This role provides guidance for the various elements of the Quality System, for example, to ensure process control, consistent manufacturing practices and identifies/recommends opportunities for continuous improvement (internal/external). Moderate level of application of the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate scope and complexity. May support both internal and external audits as an SME.

Responsibilities:

• Responsibilities include monitoring and trending quality indicators for purchased materials as well as manufactured and distributed components/products.

• Assesses Critical To Quality (CTQ) parameters and risk assessment variables as part of the decision making processes to support predictable product design and flow.

• Initiates and/or supports CAPAs and may lead the investigation/corrective action process.

• Responsible for the various aspects of Media QM Engineering as well as day to day QM Engineering responsibilities for assigned products and related operational area projects.

• Directly responsible to the Plant Quality Manager for the continued consistent implementation/application of Quality Systems as it relates to new and current product lines and Enterprise business systems.

• Is also responsible for assuring departmental compliance with ISO and FDA requirements participation on teams, assigned project support, product launches and process improvements, product quality notifications, change notifications, post market, IVDR, and customer complaints.

• This includes using Enterprise tools to ensure compliance and streamline processes.

• Position may need to support multiple sites on the Baltimore campus.

• Shift: 1st / Monday - Friday

REQUIREMENTS:

• Bachelor's degree in Biological Sciences, Chemistry, or other related science field.

• 2+ years experience in Quality or Engineering.

• On site support

PREFERRED AND ADDITIONAL SKILLS AND QUALIFICATIONS

• Experience in technical writing and executing process/test method validations.

• Experience in a medical device or pharmaceutical manufacturing facility.

• Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization ISO 13485 and 14971.

• Ability and skill to effectively manage multiple tasks and drive execution of change management plans.

• Ability and skill to lead or manage process control, supplier quality, and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC, Six sigma, additionally root cause analysis and project management techniques are routinely employed.

• Ability to effectively write communications that ensures clarity, accuracy, and consideration of the audience.

• Ability to speak with clarity and express points of view in a variety of settings; one-on one interactions, group meetings, and formal presentations.

• Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems.

• Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity.

• Knowledge of automated systems for filling and packaging are a plus.

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

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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

$73,300.00 - $121,000.00 USD Annual