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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
- Partners with R&D and other cross functional partners to ensure the proper application of
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.
- Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
- 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
- Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
- 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 analysis.
- Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data.
- Assess and interpret common versus special cause variation in manufacturing processing and
determine adequacy of current process limits.
Risk Mitigation
- Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
- Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
- Determine effectiveness of these techniques on previously implemented improvements
- Ownership and accountability of risk assessment process including conducting, documenting, reviewing or maintaining current risk and hazard analysis documentation such as Process FMEAs given product/process changes Strategic
- Conduct strategic planning with site leaders and Product Engineering Team. Partnership with other functions to establish business priorities and resource allocation
- Ensures effective quality strategies are created for the validation of test methods, process and
design
คุณสมบัติ
Qualifications:
- Bachelor’s Degree. Highly Recommended technical field.
- From 4-6 years related experience.
- Experience working in both an FDA and European regulatory environment is preferred.
- Experience with implementation of risk mitigation is preferred.
- Knowledge of product/process Risk Management (FDA and ISO standards) is required.
- Knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred
- including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- The ability to perform "hands on" troubleshooting and problem solving is preferred. Decision making based on standards, requirements, procedures and quality knowledge gained with experience.
- Basic communication of quality issues, escalations and investigations to different levels.
- Good technical understanding of manufacturing equipment and processes is required.
- Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
- A thorough understanding of GMP/ISO regulations and validation regulations is preferred
- Knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.