QMS (Plastic Industry) 1203 views1 application


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Job Description

  • Developing, implementing and maintaining Quality Management Systems (QMS) that comply with relevant standards and regulations, such as ISO 9001, ISO 13485, and FDA requirements.
  • Analyzing and evaluating the effectiveness of the QMS through internal audits, management review meetings, and corrective action management.
  • Creating and maintaining documentation related to quality standards, policies, procedures, and instructions.
  • Monitoring the product lifecycle from development to commercialization, ensuring that quality standards are met.
  • Identifying and implementing process improvements that optimize the QMS, including the development of training materials for staff.
  • Collaborating with cross-functional teams, such as R&D, engineering, and manufacturing, to ensure that quality requirements are met throughout the product development process.
  • Conducting supplier evaluations, selecting and qualifying new suppliers, and managing supplier performance.
  • Conducting risk assessments and developing risk management plans for products.
  • Participating in regulatory audits and inspections, including preparation and follow-up activities.
  • Communicating quality metrics and results to senior management and other stakeholders.

Job Requirements

  • B.Sc/M.Sc/ Btech/B.E./Diploma in Quality Management, Mechanical Engineering, Chemical Engineering, or a related field.
  • 5-10 years of experience in Quality Management Systems, preferably in the medical device, pharmaceutical, or other regulated industry.
  • Familiarity with QMS standards and regulations, such as ISO 9001, ISO 13485, and FDA requirements.
  • Experience in internal audits, CAPA management, and risk management.
  • Strong communication and interpersonal skills to effectively collaborate with cross-functional teams.
  • Excellent problem-solving and decision-making skills.
  • Ability to manage multiple projects and priorities simultaneously.
  • Strong attention to detail and ability to maintain accurate and organized documentation.
  • Experience with statistical analysis and tools for quality management.
  • Familiarity with tools for quality management, such as Six Sigma, Lean, or Total Quality Management (TQM).

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