BD (Becton, Dickinson and Company) Quality Engineer I in Baltimore, Maryland
Job Description SummaryThis position is for Engineer I. The candidate’s knowledge/skills, education, and experience will determine the position.
The QM Engineer I is responsible for the application and interpretation of the plant/department procedures to ensure consistency/compliance with Quality Systems.
Typical assignments may include: supporting one or more instrument platforms on sustaining items such as complaints, non-conformances and day to day issues, supporting audits, actively participating on teams, ensures documentation compliance, processing of CAPAs, change controls, and deviation waivers. Frequent interaction with other functional areas such as Research and Development, Operations, etc. is routine.
The QM Associate Engineer is primarily responsible for reviewing and assessing Quality Notifications, Complaints, Deviation/Waivers and other cGMP activities for the assigned product lines in the instrument plant. The QM Engineer I oversees QC operations within the instrument plant and assuring documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines. The QM Engineer I conducts complaint investigation, assists in the investigation of manufacturing issues and provides data and input on technical issues and projects.
1. Manage compliant handling, QN's, CAPA's, D/W's and trending for assigned instrumented platforms. Assist manufacturing in maintaining compliance with cGMP associated with the quality system procedural requirements for assigned platforms.
2. Drives for continuous improvement in all areas and participates on Continuous Improvement teams and recommends improvements, implements changes and verifies effectiveness of changes
3. Performs all duties in accordance with all applicable BDDS Quality, Safety and Operating Procedures.
4. Work collaboratively with suppliers to part quality.
*Ability to identify Quality issues and recommend corrective actions that can lead to resolution of general or routine complexity.
* Accesses policies and procedures for guidance.
* Capable of using Microsoft programs and ability to learn other systems.
* Basic knowledge of statistical methods and quality tools, as well as statistical application software.
* Effective verbal and written communication skills.
* The ability to work in teams, independent of supervision, to obtain planned results.
* Must be self-motivated, organized, detail oriented and have ability to multi-task.
BS or BA in related field required with no experience required.
Typical degree in Biological Sciences, Chemistry, Engineering, Computer Science and/or Regulatory Affairs or other related field.
Primary Work LocationUSA MD - Sparks - 7 Loveton Circle
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.