Quality Engineering Technician Ii

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**QUALITY ENGINEERING TECHNICIAN II**
- The quality engineering technician provides an active support to BCPs and validations.
- The quality engineering technician may supervise FG quality tech and raw material inspection tech

**You will be responsible for**:

- Generates Non-conformances records in applicable quality information system, as needed
- Performs verification of activities already completed under non-conformance reports
- Assists or executes failure investigations of non-conformances, audit findings, CAPAs, and other as indicated
- Knowledge in Quality Engineering tools such as, measurement system analysis, basic statistics analysis and other as required.
- Performs data collection and analysis, creates and distributes reports for quality metrics, initiatives, and/or plant scorecards.
- Assist Quality Engineer in line support or per given experience own line support, including the processing of change orders on Documentation control system.
- Assist Quality Engineers in driving control plan effectiveness in the mfg lines.
- Act as a liaison to manufacturing for quality related issues, as designated.
- Maintain control of protocol related materials, ensuring the applicable controls (physical and electronic) are in place and ensuring parties are notified according to Ethicon procedures.
- Follows up with the protocol owners for the disposition of protocol materials.
- Generates and controls the applicable forms (QA to QA forms) for the transfer of protocol or non-conformance materials between Ethicon sites.
- Ensures the environmental / microbiology testing is executed according to the plan; samples are timely collected and submitted for testing according to Ethicon procedures.
- Follows J&J and Records Management Policies for Convenience Information, Records Retention Schedules, Training and Education, Document Hold Notices & Records Cleanout.Maintains, and provides information such as quality records from the company's quality information systems
- May act as an administrator of local quality information systems
- Responsible in complying with Good Manufacturing Practices (GMPs), Regulations, International Standards, Environmental, and Health Policies
- Follows all company safety policies and other safety precautions within the work area
- Ensures compliance with safety policies and proceduresEnsures compliance with Environmental Management System(EMS) responsibilities
- Ensure compliance with Quality systems policies and procedures
- Support protocol and execution of Test Method validation and/or Equipment validation.
- Performs Device History Records review and product release (including sterilizationinformation as delegate). These activities require previous training on the applicable procedures.
- Verifies that information for rejected material is correctly identified and entered in nonconforming system as material is segregated.
- Controls non-conforming components returned from the production floor.
- Responsible for tagging material, verify material on hold status in applicable system, logging material in cage, and updating database.
- Witness of the appropriate destruction of non-conforming material following the applicable procedures.
- Help maintain a document retention system for the Juarez facility.
- Coordinates and actively participates on quarterly quality communication meetingsParticipates on departmental and company continuous improvement activities on Kaizen blitz, Kaizen or Green belt certification projects.
- Provide coaching and support to quality technician on yellow and orange belt projects.
- Participate in Test Method and Equipment validations.
- Perform change order for document revision as applicable.
- Assure that Bioburden, Dose Audit, In Vitro samples are segregate and send to laboratory.
- Tracking Laboratory samples and results.
- Provide support during External and Internal Audits (e.g.: document retrieval, consultation, etc.)
- Responsible for communicating business related issues or opportunities to next management level

**Qualifications** Requirements and Education**:

- A minimum of High School Diploma or equivalent is required
- From 2 to 4 years related experience.Or currently pursuing an Engineering Bachelor’s Degree preferred
- 25-50% proficient in English

**Knowledge and Skill Sets**:

- GMP/ ISO knowledge preferred.
- Knowledge of