Quality Assurance Officer

Overview
We are seeking a highly motivated and detail-oriented Quality Assurance Officer to join our dynamic manufacturing team. In this pivotal role, you will champion the integrity of our products by ensuring they meet stringent quality standards and regulatory requirements. Your proactive approach will help us maintain excellence across all processes, from initial inspection to final quality control, fostering continuous improvement and customer satisfaction. This is an exciting opportunity for someone passionate about quality management and eager to make a tangible impact in a fast-paced environment.

Duties

• Conduct comprehensive quality inspections using precision measuring instruments such as calipers, micrometers, and vision inspection systems to verify product specifications.
• Perform regular quality audits in accordance with ISO 9001, ISO 13485, and other relevant standards to identify areas for improvement.
• Ensure compliance with FDA regulations, HACCP, CGMP, and other industry-specific standards throughout manufacturing processes.
• Utilize Calypso software for data collection, analysis, and reporting to monitor quality metrics and support decision-making.
• Coordinate measurements with coordinate measuring machines (CMM) to verify dimensional accuracy of complex components.
• Lead root cause analysis for quality issues, implementing corrective actions to prevent recurrence.
• Support the implementation and maintenance of robust quality systems that align with ISO 9001 and ISO 13485 standards.
• Conduct internal and external quality audits, preparing detailed reports and follow-up actions to uphold certification requirements.
• Collaborate with manufacturing teams to ensure adherence to quality control procedures during production runs.
• Maintain accurate documentation of inspections, audit findings, calibration records, and non-conformance reports.

Skills

• Strong knowledge of quality management principles, including QA/QC practices within manufacturing environments.
• Proficiency with calibration tools such as calipers, micrometers, and precision measuring instruments.
• Experience working with vision inspection systems and other automated inspection technologies.
• Familiarity with industry standards including ISO 9001, ISO 13485 (medical devices), FDA regulations, HACCP, CGMP standards.
• Ability to perform detailed analysis using data collection tools like Calypso software for trend analysis and reporting.
• Excellent problem-solving skills with the ability to conduct root cause analysis effectively.
• Strong communication skills for documenting findings clearly and collaborating across departments.
• Attention to detail in performing quality inspections and audits to ensure compliance with regulatory requirements.
• Knowledge of calibration procedures for coordinate measuring machines (CMM) and other precision instruments. Join us as a Quality Assurance Officer if you’re ready to uphold the highest standards of product excellence while advancing your career in a vibrant industry!

Job Types: Full-time, Permanent

Pay: $28.00 - $30.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Vision insurance

Experience:

• Quality assurance: 5 years (Preferred)

Work Location: In person