Senior Quality Engineer

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We are searching for the best talent for Senior Quality Engineer to be in Juarez, Chih. MX. Salvarcar Plant

Purpose:
Under the direction of Quality Operations Lead and with the objective of maintaining high quality standards for the product manufacturing process and compliance with regulatory requirements, administers Finished Goods Quality technicians and/or Quality Engineering technicians to support the Supply Chain including Project support, in day to day activities as failure investigation and data analysis, supporting manufacturing lines, operator certification program, incoming and finished good inspections, and CME environmental monitoring, all in accordance with applicable regulations and Ethicon written specifications and quality standards.

You will be responsible for:
Responsibilities may include, but are not limited to:
The Quality Engineer utilizes Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality requirements and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business.

Business Improvements
- Support quality improvement initiatives such as process and product characterizations that lead

to continuous / cost improvements.
- Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other

improvement tools and programs.
- Conduct benchmarking with external companies or internal sites to develop more effective

methods for improving quality
- Supports the development of quality engineering and quality compliance with the right skill sets

for new product introductions, and product life cycle management.
- Compliance/Regulatory
- Review/analyze whether current product and processes (including actions or decisions

conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
- Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
- Conduct periodic line audits to assess for production controls such as lot segregation. Review

results of area audits to ensure that corrective and preventive actions are adequate.

New Product/Process Introduction

design controls, risk management and the investigation/correction of design failures/challenges.
- Supports the development of quality strategies related to the transfer of products, materials and components within J&J or externally. Supports new product introduction as part of design transfer

People
- As applicable, provides supervision, mentoring, coaching, performance review, and

developmental plans for others

Product Quality, Control & Disposition and Performance Standards
- Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Analyze/review effectiveness of preventive and corrective actions. Review root cause

investigation according to an established process.
- Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality

Product/Process Qualification
- Approve IQ, OQ, PQ, TMV or Software Validation Production/Process Controls including Control Plans
- Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan
- Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes
- Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
- Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
- Develop, interpret and implement standard and non-standard sampling plans
- Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system