Job Description Summary
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.
The Sr Quality Engineer has responsibility for applying/interpreting the applicable Quality Systems, developing/implementing Standard Operating Procedures and Quality policies. Develops and fosters an inclusive working relationship across all job functions that support the Media/IDAST plants. 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.
Is also responsible for assuring departmental compliance with ISO and FDA requirements through supporting internal and external audits, participation on teams, assigned to lead or support projects, product launches and process improvements, and coordination and resolution of CAPAs. Deploy the use of statistical technique/tools such as: Statistical sampling, SPC, Six sigma, root cause analysis techniques.
In this role the primary responsibilities include:
The role will have primary responsibility for supplier management for 250 Schilling, 39L and IDAST.
Monitoring and trending quality indicators for purchased materials as well as manufactured and distributed components/products.
Initiates SCARs for supplier issues
Initiates and/or supports CAPAs and may lead the investigation/corrective action process related to supplier or internal concerns.
Support and/or conduct supplier audits
Assesses Critical To Quality (CTQ) parameters and risk assessment variables as part of the decision making processes to support predictable product design and flow.
Responsible for aspects of Media/IDAST QM Engineering as well as the day to day QM Engineering responsibilities for assigned product and related operational areas. This includes but not limited to, product quality notifications, change notifications and customer complaints.
Experience/Education:
Degree preferred in Biological Sciences, Chemistry or other related science/technology field.
Minimum 3 years experience in Quality or Supplier Management or Engineering.
Desired knowledge, skill and ability include:
Experience in a medical device or pharmaceutical manufacturing facility.
Knowledge and understanding of the Food and Drug Administration (FDA) and International Organization for Standardization ISO 13485
Ability and skill to effectively manage multiple tasks and drive execution of management plans
Effective written and verbal communication skills that ensures clarity, accuracy and consideration
of the audience
Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems
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 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.
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
