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Quality Assurance Leader
2 months ago
This position is accountable for managing a team dedicated to inspection and quality assurance processes related to procured materials, in-process components, and final products to ensure adherence to quality benchmarks. The individual will supervise personnel engaged in measuring and evaluating products, as well as gathering and interpreting data regarding material, product, or process quality and dependability.
Key Responsibilities:
- Team Leadership: Guide and oversee staff involved in inspection and quality assurance for materials and products. Ensure consistent compliance with quality control benchmarks.
- Quality Initiatives: Manage quality initiatives and protocols across various facilities. Travel may be necessary to fulfill objectives.
- Task Management: Organize and delegate tasks to team members, develop and modify inspection tools, and propose enhancements to processes, standards, and equipment.
- Testing and Equipment: Establish programs to assess the precision and reliability of production and testing instruments. Enhance and maintain testing, measurement, and analytical facilities.
- Issue Resolution: Investigate issues or instances of noncompliance, identify corrective measures, and implement root cause analysis.
- Record Keeping: Compile and sustain inspection documentation and reports. Analyze causes of defective work and provide guidance to production supervisors on corrective actions.
- Standards Creation: Formulate and execute standards and methodologies for inspection, testing, and evaluation. Develop procedures for material assessment and cost evaluation.
- Operational Improvement: Examine and address operational challenges, assist team members with problem-solving, and recommend changes to enhance safety and efficiency.
- Client Feedback: Address client complaints, perform on-site assessments, implement corrective actions, and liaise with relevant departments.
- Compliance Management: Uphold cGMP standards in line with regulations and prepare for and lead audits by clients and regulatory authorities.
- Additional Responsibilities: Execute other tasks as assigned.
Travel Expectations:
- 20%-30% travel may be necessary.
Qualifications:
- Education: A Bachelor's degree in a technical discipline is preferred.
- Experience: 5-10 years of experience in Quality Assurance or a related domain, with a proven history as a Quality Assurance Manager in technology-oriented, evolving organizations.
- Regulatory Acumen: Familiarity with FDA, OSHA, and International Quality System regulations is essential.
- Skills: Excellent verbal and written communication, interpersonal skills, and organizational capabilities. Initiative, confidentiality, ability to meet deadlines, and teamwork skills are crucial.
- Technical Skills: Proficiency in PC-based applications (Word, Excel, PowerPoint, and database/documentation software) is mandatory.