BD (Becton, Dickinson and Company) Quality Engineer II in Franklin Lakes, New Jersey
Job Description SummaryUnder the direction of their reporting Manager, manages activities and procedures associated with World Wide (WW) complaints concerning BD Diabetes Care and BD Medical/Surgical- Injection business unit products. This position actively participates in the investigation of WW Customer complaints, Quality experiments, analysis, as well as support all Product Team platforms. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.
Moderate level application of technical principles, theories, concepts, techniques and quality sciences / tools. This includes FTIR and / or SEM analysis.
Develops solutions to routine problems of moderate scope, i.e. critical thinking.
Follows company procedures and makes basic procedural updates.
Developing working knowledge of applicable regulatory, Corporate and/or Unit requirements. Specifically: Ensure Customer complaint investigations, procedures, and other activities comply with FDA Quality System Regulations, ISO, and Medical Device Directives for Vigilance.
Communicates across functions / departments for assigned areas of responsibility. Identify trends and quality issues raised during an investigation and escalate appropriately.
Is an extended team member representing Quality on new product development projects and a team member for sustaining engineering projects.
Provides audit support (preparation, closure, etc. activities).
Maintain good laboratory practices (GLP) consistent with regulatory requirements.
Contributes to the completion of milestones associated with specific projects.
Prepares reports, including quantitative / qualitative analysis, summaries and protocols.
May be expected to make presentations.
Typically requires a minimum of a Bachelor’s Degree
Must have knowledge of product failure modes.Demonstrate competence in mechanical and functional disciplines.Product knowledge of intended use and be able to differentiate between significant and non-significant health risks.Strong analytical, deductive reasoning and listening skills.
A minimum of 2 years relevant experience or a combination of equivalent education and relevant experience.
High level of problem identification, analysis, and formulation of conceptual / technical and business solutions.
Moderate knowledge of applicable regulatory, Corporate and/or Unit requirements.
Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction 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.
Primary Work LocationUSA NJ - Franklin Lakes
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