Ingeniero De Calidad Jr

POSITION DESCRIPTION

POSITION TITLE: JR QUALITY ASSURANCE ENGINEER

Assure products are manufactured to be safe and effective and meet the customer’s needs under the supervision of the Quality Assurance Engineer. Responsible for quality issues pertaining to production.   Interface with other engineering groups, on quality related Manage the Quality function in a particular manufacturing area by developing and maintaining quality control plans, dealing with non-conforming material, customer complaints, CAPA’s and providing Quality metrics to Manufacturing and Quality Management all this under the supervision of the Quality Assurance Engineer.   Assure the manufacturing areas are compliant to regulations and GMP and support continuous improvement activities for improved quality and production.

DUTIES AND RESPONSIBILITIES:

1.   In conjunction with the Production Manager, Quality Assurance Engineer, Supervisors, Engineers, and Maintenance personnel, Troubleshoot and identify production floor quality problems through analysis and interpretation of   inspection and process data.

2.   Responsible for work under supervision in the documentation, disposition, root cause and corrective action activities of non-conforming material.

3.   Responsible for work under supervision in the investigation, documentation, root cause and corrective action activities of customer complaints and communicate the results to the appropriate production, engineering and regulatory compliance personnel.

4. Support in the development of quality plans, inspection methods and review and approve manufacturing SOPs.

5. Support and Manufacturing and Quality process improvements projects as an effective team member/leader using     continuous improvement tools, supporting Lean Blitzes and Six Sigma Projects.

6.   Support the Quality Department by performing Internal and supplier audits.

8.   Work with the day to day activities for the disposition of Non-conforming material, Root Cause analysis, Corrective action implementation, CAPA Closure and effectiveness review, Document review and approvals.

9.  Work closely with Quality Assurance Engineer and Manufacturing Engineers to report, analyze and

      summarize quality trend data to aid in the implementation of continuous improvement opportunities.

10.  Support Quality System improvement projects to effectively meet mutually agreed upon goals.

11. Assist in the execution of Validation Protocol, Engineering Studies and MSA’s protocol.

12. Comply with all local, state, federal, and BD safety regulations, policies, and procedures including

      RCRA Hazardous waste regulations.

13. Comply with all local BD quality policies, procedures, and practices through consistent application of

      sound quality  assurance principles.

14. Other duties as assigned.

EDUCATION AND EXPERIENCE REQUIREMENTS

• BS Degree in Engineering or a related science field.

• Six-Sigma Green belt and Lean manufacturing training is preferred.

Skills: 

• Knowledge on Statistical analysis and tools
• Knowledge on GMP and QSR
• Knowledge on ISO requirements