Job Description Summary

　　The Quality Engineer II has responsibility for applying/interpreting the applicable Quality Systems, developing/implementing Standard Operating Procedures and Quality policies, with a focus on validation writing and execution. Develops and fosters an inclusive working relationship across all job functions that support the Media plants.

　　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.

　　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. Writes and drives change validations and executes reoccurring validations/qualifications for the media plants and IDAST. 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 controls, post market, IVDR, and customer complaints. This includes using Enterprise tools to ensure compliance and streamline processes.

　　Other duties as assigned based on business needs.

　　REQUIREMENTS

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

　　Minimum 2 years experience in Quality, Scientific Operations, or Engineering.

　　On site support

　　PREFERRED AND ADDITIONAL SKILLS AND QUALIFICATIONS

　　Experience in technical writing and managing process and test method validations.

　　Experience in a medical device or pharmaceutical manufacturing facility.

　　Basic 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.

　　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 encourage people with the creativity and aim 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.

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

　　Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

　　PDN

　　Primary Work Location

　　USA MD - Hunt Valley

　　Additional Locations

　　Work Shift

　　NA (United States of America)

　　Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.