BD (Becton, Dickinson and Company) Sr. Quality System Specialist / Data Analyst in Vernon Hills, Illinois

Job Description Summary

Job Description

USA IL - Vernon Hills

As directed by the Quality Manager, the Sr. Quality System Specialist is accountable for support of the continued development, improvement and implementation of the Quality Systems. This position actively participates in quality guidance, product resolution decisions and statistical problem solving techniques to post market surveillance for process improvement and continuous improvement activities.

  • Consistent application of Quality system standards to assigned Quality system area.

  • Develops solutions to routine assigned activities of moderate scope & complexity.

  • Follows applicable Company / Unit procedures and may make updates to procedures and policies

  • Works within and across functions for assigned Quality systems

  • Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements

  • Responsible for robust post-production monitoring and feedback into design and manufacturing that goes beyond base compliance requirements.

  • Develops post-market surveillance metrics and measurement systems (i.e. trends, Pareto analysis, and statistical analysis) that enable meaningful strategies to be constructed for optimal root cause resolution, customer satisfaction, and regulatory compliance.

  • Facilitates cross-functional interaction and communication between QRA, R&D, Manufacturing, Operations, Sales, and Marketing related to the customer experience and expectations.

  • Participates and supports external regulatory site visits and audits and responds to complaint management audit findings.

  • Works under general direction.

  • Independently determines and develops approach to solutions.

  • Designs and performs development working independently within defined parameters with minimal supervision required

  • May provide guidance and work direction to lower level project developers

  • Develops solutions to routine assigned activities of moderate scope & complexity.

Requirements:

  • Bachelors Degree degree in Life Sciences, Engineering, or similar field

  • A minimum of 3- 5 years relevant experience or a combination of equivalent education and relevant experience in technical/analytical experience in complaint management.

  • Experience working in the Medical Device and/or Pharmaceutical regulated industry within Quality highly desired.

  • Experience in Trackwise and SAP

  • Excellent Excel skills including experience with Macros and validation of spreadsheets required

  • Document Handling experience required

  • Proficiency in Microsoft PowerPoint and Mini-tab applications

  • Experience in Qlikview is a plus

  • Excellent communication skills at all levels both written and verbal

  • Strong analytical, technical, and problem solving skills required

  • Effective meeting and presentation skills

  • Consistent application of Quality system standards to assigned Quality system area.

  • Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements.

Certifications (if applicable):Industry Recognized certification in a Quality System Element specialty (e.g. ASQ Quality Engineer) preferred.

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.

#LI-OPS

Primary Work LocationUSA IL - Vernon Hills

Additional LocationsUSA NJ - Franklin Lakes

Work Shift

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