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Principal Quality Assurance Specialist
2 weeks ago
**Overview**
We are seeking a highly motivated and detail-oriented Principal Quality Assurance Specialist to lead our quality assurance initiatives across manufacturing and product development processes. In this pivotal role, you will champion the integrity of our quality systems, ensure compliance with industry standards and regulations, and drive continuous improvement. Your expertise will help uphold the highest standards of quality, safety, and efficiency, enabling us to deliver exceptional products to our customers worldwide. This is an exciting opportunity for a seasoned professional passionate about quality management and eager to make a significant impact.
**Duties**
- Lead the development, implementation, and maintenance of comprehensive quality assurance programs aligned with ISO 13485, ISO 9001, CGMP (Current Good Manufacturing Practices), and FDA regulations.
- Conduct rigorous quality audits across manufacturing facilities to verify adherence to established standards and identify areas for improvement.
- Oversee calibration and validation of precision measuring instruments such as Calipers, Micrometers, Coordinate Measuring Machines (CMM), and Vision Inspection Systems to ensure measurement accuracy.
- Manage inspection processes utilizing advanced quality control tools including vision inspection systems, calipers, micrometers, and other precision measuring instruments.
- Coordinate internal and supplier audits to evaluate compliance with HACCP (Hazard Analysis Critical Control Point), ISO standards, and regulatory requirements.
- Analyze data collected from inspections, audits, and testing to identify trends, root causes of issues, and opportunities for process enhancements.
- Collaborate with cross-functional teams to develop corrective actions, preventive measures, and continuous improvement initiatives that elevate overall product quality.
**Requirements**:
- Bachelor’s degree in Engineering, Quality Management, or a related field; advanced certifications in quality assurance or regulatory affairs are preferred.
- Extensive experience in manufacturing environments with a focus on quality assurance or quality control roles.
- Strong knowledge of industry standards including ISO 13485 (medical devices), ISO 9001 (quality management systems), FDA regulations, HACCP principles, and CGMP guidelines.
- Proficiency in using calibration tools such as calipers, micrometers, coordinate measuring machines (CMM), and vision inspection systems for precise measurement tasks.
- Demonstrated ability to perform comprehensive quality audits and assessments within complex manufacturing settings.
- Excellent analysis skills with the ability to interpret data from various sources for informed decision-making.
- Familiarity with quality management software systems and data collection tools used in QA/QC processes.
- Exceptional communication skills to effectively lead audits, training sessions, and cross-departmental collaborations. Join us as a Principal Quality Assurance Specialist if you’re ready to lead with passion, uphold rigorous standards, and contribute to innovative products that make a difference globally
Pay: $121,500.00-$161,700.00 per hour
Expected hours: 40 per week
**Benefits**:
- Dental care
- Paid time off
- Vision care
Work Location: Remote
