QA Manager

1 week ago

mumbai, India Suvarna and Associates Full time
Opening: QA Manager in Riyadh Saudi Arabia
We are seeking a QA Manager for an emerging Medical Device Company in Riyadh Saudi Arabia specializing in Advanced Wound Care and Infection Management. The company is in the early stages of production and is preparing to bring its products to market in the coming months. This is an exciting opportunity to join an exceptional team and gain international exposure.The first round of interviews will be conducted online with the final interview taking place in Mumbai (details to be provided upon initiation).
Job Description and Qualifications
Education:
  • Required: Bachelor s degree in engineering life sciences or a related field. Common degrees include Biomedical Engineering Mechanical Engineering or Biochemistry.
  • Preferred: Advanced Degree (Master s or higher) in a specialized field or for higherlevel positions.

Experience:
  • Industry Experience: 510 years in the medical device industry with a focus on quality assurance quality control or regulatory affairs.
  • Management Experience: 35 years in a managerial or supervisory role overseeing QA teams and processes.
  • Regulatory Knowledge: Extensive experience with regulatory requirements such as ISO 13485 and other relevant standards.

Skills and Competencies:
  • Quality Management Systems (QMS): Indepth knowledge and experience in implementing and maintaining QMS.
  • Auditing: Experience in conducting internal and external audits including supplier audits.
  • ProblemSolving: Strong analytical skills for addressing quality issues and implementing corrective and preventive actions (CAPA).
  • Documentation: Proficiency in developing reviewing and managing qualityrelated documentation.
  • Communication: Excellent skills for coordinating with crossfunctional teams senior management and regulatory bodies.
  • Attention to Detail: High attention to detail to ensure compliance and product quality.
  • Leadership: Strong leadership skills to effectively manage and mentor QA team members.
  • Language Skills: Fluent in verbal and written English.

Job Responsibilities:
  • Corrective and Preventive Actions (CAPA): Implement and manage CAPA processes to address product and process nonconformities.

  • Supplier Quality Management:

  • Supplier Evaluation: Evaluate and approve suppliers conduct supplier audits and monitor supplier performance.
  • Incoming Inspection: Ensure the quality of incoming materials through inspection and testing.

  • Continuous Improvement:

  • Process Improvement: Identify and implement process improvements to enhance quality and efficiency.
  • Training and Development: Provide training on quality policies procedures and regulatory requirements.

  • Complaint Handling and PostMarket Surveillance:

  • Complaint Investigation: Manage the investigation of customer complaints and ensure timely resolution.
  • PostMarket Surveillance: Oversee activities to monitor product performance and safety in the field.

  • Team Leadership:

  • Team Management: Lead and mentor the QA team providing guidance and support
  • CrossFunctional Collaboration: Work with other departments (e.g. R&D manufacturing regulatory affairs) to ensure quality objectives are met.

  • Reporting:

  • Quality Metrics: Develop and track key quality metrics and generate regular reports for senior management.
  • Management Reviews: Conduct reviews to evaluate the effectiveness of the QMS and identify areas for improvement.

documentation,problem-solving,cross-functional collaboration,continuous improvement,reporting,complaint handling and post-market surveillance,regulatory affairs,iso standards,management reviews,training and development,leadership,auditing,quality assurance,quality management systems (qms),team leadership,supplier quality management,quality control,total quality management (tqm),quality auditing,communication

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