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)