BD (Becton, Dickinson and Company) Quality Engineer I in Sparks, Maryland
Job Description SummaryThe Quality Engineer I is responsible for gaining experience in the application and interpretation of the plant/department procedures to ensure consistency/compliance with Quality Systems.
Learning to apply the Quality Systems to ensure compliance as well as having the knowledge necessary to apply the appropriate statistical and analytical tools. Works with various enterprise systems/Corporate directives to support new and/or current product lines and processes.
Typical assignments may include: developing/implementing tasks associated with plant activities or projects of general complexity within planned schedules/timelines, supporting audits, participating on teams, ensures documentation compliance, processing CAPAs, change control, and deviation waivers. Routine interaction with other functional areas such as Operations and other Quality groups.
Reviewing and assessing Quality Notifications, Complaints, Deviation/Waivers and other cGMP activities for the assigned product lines in the instrument plant.
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.
Conducts complaint investigation, assists in the investigation of manufacturing issues and provides data and input on technical issues and project
Manages compliant handling for assigned instrumented platforms.
Assists manufacturing in maintaining compliance with cGMP associated with the quality system procedural requirements for assigned platforms.
Drives for continuous improvement in all areas and participates on Continuous Improvement teams and recommends improvements, implements changes and verifies effectiveness of changes
Performs all duties in accordance with all applicable Quality, Safety and Operating Procedures.
Works 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
Typical degree in Biological Sciences, Chemistry, Engineering, Computer Science and/or Regulatory Affairs or other related field.
1-2+ years experience preferred, but not required
Primary Work LocationUSA MD - Baltimore
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