Quality Systems Manager

1 week ago


Dover, Delaware, United States FalconSmartIT Full time

Job Title : Quality Systems Manager

Location: Phoenix, AZ

Job Type : Full Time

Key Responsibilities:

  1. Quality System Development:
  • Develop, implement, and maintain the organization's quality management system in accordance with industry standards and regulatory requirements.
  • Establish and document quality policies, procedures, and processes.
  1. Compliance Management:
  • Stay abreast of relevant quality standards, regulations, and industry best practices.
  • Ensure that the organization complies with all applicable quality and regulatory requirements.
  1. Documentation and Recordkeeping:
  • Oversee the creation and maintenance of quality-related documentation, including standard operating procedures, work instructions, and quality manuals.
  • Ensure accurate and complete recordkeeping of quality-related data.
  1. Audits and Assessments:
  • Plan and conduct internal and external audits to assess compliance with quality standards.
  • Collaborate with regulatory bodies, customers, and external auditors during external audits.
  1. Continuous Improvement:
  • Implement processes for continual improvement of the quality management system.
  • Analyze data and metrics to identify opportunities for improvement and risk mitigation.
  1. Training and Communication:
  • Develop and deliver training programs on quality processes and procedures.
  • Facilitate communication regarding quality issues and updates across the organization.
  1. Cross-Functional Collaboration:
  • Collaborate with other departments, including production, R&D, and supply chain, to ensure quality standards are integrated into all processes.
  • Provide guidance on quality considerations during new product development.
  1. Quality Metrics and Reporting:
  • Establish and monitor key performance indicators (KPIs) to measure the effectiveness of the quality management system.
  • Prepare and present regular reports on quality performance to management.

Qualifications:

  • Bachelor's degree in a relevant field (Quality Management, Engineering, or related discipline).
  • Several years of experience in quality management, with a focus on quality systems.
  • In-depth knowledge of relevant quality standards (ISO 9001, ISO 13485, etc.) and regulatory requirements.
  • Experience with auditing processes and managing audit programs.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.
  • Certification in quality management (e.g., ASQ Certified Manager of Quality/Organizational Excellence) is a plus.

Personal Attributes:

  • Attention to detail and accuracy.
  • Strong organizational and project management skills.
  • Ability to lead and influence cross-functional teams.
  • Commitment to continuous learning and improvement.

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