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Quality Assurance Specialist

hace 2 meses


Oaxaca, Oaxaca, México Johnson & Johnson Sa De Cv A tiempo completo
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at Johnson & Johnson Sa De Cv. As a Quality Assurance Specialist, you will be responsible for ensuring the highest quality standards for our products and processes.

Key Responsibilities
  • Administer Finished Goods Quality technicians and/or Quality Engineering technicians to support the Supply Chain, including Project support, in day-to-day activities such 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.
  • Utilize Quality Engineering tools and practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
  • Apply Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality requirements and Business vision.
  • 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.
  • Support the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
  • Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance with standards such as the QSRs, ISO 13485, etc.
  • Champion 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.
  • Support 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.
  • Provide supervision, mentoring, coaching, performance review, and developmental plans for others.
  • 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.
  • Approve IQ, OQ, PQ, TMV, or Software Validation.
  • Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plans.
Requirements
  • High school diploma or equivalent required.
  • Minimum 2 years of experience in Quality Assurance or related field.
  • Strong knowledge of quality principles, regulations, and standards.
  • Excellent communication and problem-solving skills.
  • Ability to work in a team environment.