Senior Quality Engineer

at  BD

JOB DESCRIPTION SUMMARY

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 plants.
This role provides mentorship 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. Will support both internal and external audits as an SME. This is an individual contributor role at the 250 Schilling Circle Media Plant supporting the PPM operation.

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.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree from a four-year college or university in sciences or other relevant technical field preferred.
• 3+ years experience with degree in Quality Engineering or other related field. 6+ years experience within the medical device/pharm industry in lieu of degree
• Experience in a medical device, pharmaceutical manufacturing facility, or other relevant manufacturing field.
• Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience
• Proficient in using a computer including software such as Microsoft suite, TEAMs, and Adobe Acrobat.

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.
• Proactively leading multiple tasks and drive execution of organizational change plans
• Lead or innovate process control, supplier quality and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC. Minitab experience is a plus.
• Six sigma, Lean Tools, root cause analysis, and project management techniques are routinely employed
• 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.
  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.

• Reviewing 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.
• Responsible for aspects of Media QM Engineering as well as the day to day QM Engineering responsibilities for assigned product and related operational areas.
• Directly responsible to the Plant Sr 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 through supporting internal and external audits, participation on teams, assigned project support, product launches and process improvements, and coordination and resolution of CAPAs, product quality notifications, change notifications and customer complaints.
• Ability to use root cause analysis tools and execute corrective action plans
• This includes using Enterprise tools to ensure compliance and streamlining the processes.