- 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.
- 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.
- 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.
- 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.
- Continuous Improvement:
- Implement processes for continual improvement of the quality management system.
- Analyze data and metrics to identify opportunities for improvement and risk mitigation.
- Training and Communication:
- Develop and deliver training programs on quality processes and procedures.
- Facilitate communication regarding quality issues and updates across the organization.
- 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.
- 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.
- 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.
- 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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Quality Systems Manager - Dover, United States - FalconSmartIT
Description
Job Title : Quality Systems Manager
Location: Phoenix, AZ
Job Type : Full Time
Key Responsibilities:
Qualifications:
Personal Attributes:
