Job Summary
We are seeking a detail-oriented and experienced QA Specialist to join our manufacturing team. The ideal candidate will be responsible for ensuring product quality through rigorous inspection, analysis, and adherence to industry standards such as ISO 13485, ISO 9001, and FDA regulations. This role involves implementing quality management systems, conducting audits, and utilizing precision measuring instruments to maintain the highest quality standards across all processes. The QA Specialist will play a critical role in maintaining compliance with regulatory requirements and supporting continuous improvement initiatives within the organization.
Responsibilities
- Conduct comprehensive quality inspections using precision measuring instruments such as calipers, micrometers, and vision inspection systems to verify product specifications.
- Perform quality audits in accordance with ISO 13485, ISO 9001, CGMP, HACCP, and FDA regulations to ensure compliance across manufacturing processes.
- Analyze data collected from inspections and testing to identify trends and areas for process improvement.
- Utilize Calypso software for data management and reporting related to quality assurance activities.
- Coordinate measuring machine (CMM) operations to verify dimensional accuracy of components.
- Maintain detailed documentation of inspection results, non-conformances, and corrective actions in compliance with quality systems standards.
- Support manufacturing teams by providing guidance on quality control procedures and best practices.
- Assist in the development and implementation of quality management systems aligned with industry standards.
- Participate in root cause analysis and problem-solving activities related to product defects or process deviations.
- Conduct internal quality audits and support external audits to ensure ongoing compliance with regulatory requirements.
Requirements
- Proven experience in manufacturing quality control or assurance roles within regulated industries such as medical devices or pharmaceuticals.
- Strong knowledge of ISO 13485, ISO 9001, FDA regulations, CGMP, HACCP, and related quality standards.
- Proficiency with Calypso software and familiarity with calibration tools such as calipers, micrometers, and vision inspection systems.
- Experience operating coordinate measuring machines (CMM) and other precision measuring instruments like micrometers and calipers.
- Excellent analysis skills with the ability to interpret complex data sets for decision-making purposes.
- Strong understanding of quality management principles including QA/QC processes, quality audits, and continuous improvement methodologies.
- Ability to perform detailed quality inspections using various measurement tools and vision systems.
- Effective communication skills for reporting findings and collaborating with cross-functional teams.
- Attention to detail with a focus on maintaining high standards of accuracy and compliance in all tasks. This position offers an opportunity to contribute significantly to maintaining our organization’s reputation for excellence in product quality while working within a dynamic team committed to continuous improvement.
Job Types: Full-time, Permanent
Pay: $24.00 - $26.50 per hour
Expected hours: 40 per week
Work Location: In person
