Staff Quality Engineer I - United States
Becton Dickinson (company)
The incumbent will be responsible primarily for support of PAS Sustaining Engineering activities and general Quality Assurance tasks related to PAS products, as needed.
The position requires a self-motivated, self-directed individual able to handle multiple projects and tasks utilizing a high level of written and oral communication skills. In addition the incumbent may be expected to initiate quality initiative projects, become thoroughly knowledgeable with all aspects of sustaining engineering and/or new product development projects and assume personal responsibility for the successful completion of all tasks within the realm of quality engineering responsibilities.
The Staff Quality Engineer I reports to the Associate Director, PAS Quality Engineering (Franklin Lakes) with a dotted line report to the plant Quality Manager. The incumbent’s work location will be in the Broken Bow, NE manufacturing facility.
- Provide manufacturing line support, including but not limited to deviations, non-conforming product, complaint investigations and failure investigations.
- Provide local quality engineering project support, including but not limited to continuous improvement and sustaining engineering projects.
- Serve as a multi-functional team member establishing quality requirements and providing guidance for sustaining engineering projects.
- Lead or support Risk Management (in accordance with ISO14971). Evaluation of current products, as well as, new products being developed.
- Develop and implement quality improvement programs
- Develop and review validation protocols for effectiveness and compliance to Corporate Guidelines.
- Assist and/or generate field issue investigation (Situation Analysis) reports and assure timely close-out of all required actions associated with the process.
- Assess current operations for quality and compliance.
- Develop methods to measure, validate and assure quality standards are achieved for applicable product lines.
- Serve as a multi-functional team leader for quality improvement teams assuring commitments and objectives are achieved with positive results.
- Maintain documentation for compliance and effectiveness.
- QUALIFICATIONS AND REQUIREMENTS
Minimum Education and Experience:
Required: Bachelor's degree in Engineering or related technical field
Minimum 5 yrs. minimum experience in Medical Device or Pharmaceutical Industry
Ten yrs. Experience in Medical Device or Pharmaceutical Industry
License and/or Certification
CQE and Six Sigma Certification (Black Belt preferred)