Staff Quality Engineer II
Job Description Summary
Position is responsible for assuring quality standards and regulatory compliance are consistent with Corporate and Division Policies, Government Regulations, International Standards and Standards of the Medical Device Industry.
The incumbent will be responsible for supporting new product development and product maintenance through the use of Quality Engineering Skills.
The position requires the application of the 6 sigma process methodology to be used and documented for multiple projects.
The position requires the ability to handle multiple projects and tasks utilizing a high level of written and oral communication skills.
- Provide Quality engineering support to all assigned projects, manufacturing facilities and suppliers.
- Function as a Quality Representative in cross-functional teams
- Assess current operations for quality and compliance
- Own and facilitate product Risk Management activities
- Develop & implement quality improvement programs
- Ensure Design Control Elements are satisfied
- Assist/conduct Failure Investigations and problem solving sessions
- Lead general engineering projects
- Bachelor Degree Science or related field
- 5-10 years Quality Engineering experience or 12+ years industry experience (Healthcare/ Pharmaceutical
- Thorough understanding of Statistical Methods for Quality Assurance
- Thorough working knowledge and utilization of the 6 sigma process methodology
- Thorough understanding of industry regulations: QSR/cGMP, ISO QM standards
- Good written and oral communication skills
- Excellent problem solving and analytical skills
- Excellent time-management skills
- Ability to handle multiple projects simultaneously with minimal supervision
- Ability to thoroughly evaluate, clearly understand and communicate all aspects of assigned project.
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.
Primary Work LocationUSA NJ - Franklin Lakes
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"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
Anonymous, Franklin Lakes, NJ