Job Overview We are seeking a highly motivated and detail-oriented Quality Assurance Engineer to join our dynamic manufacturing team. In this pivotal role, you will champion the integrity of our products by ensuring compliance with rigorous quality standards, regulatory requirements, and industry best practices. Your expertise will drive continuous improvement initiatives, uphold safety and quality protocols, and foster a culture of excellence across all production processes. If you thrive in a fast-paced environment and are passionate about delivering top-tier quality, this is the opportunity for you to make a meaningful impact. Responsibilities Develop, implement, and maintain comprehensive quality management systems aligned with ISO 9001, and other relevant standards. Conduct regular quality audits to verify adherence to internal policies and regulatory standards. Perform detailed quality inspections and control checks throughout the production cycle to identify defects or deviations from specifications. Analyze quality data using Six Sigma methodologies and GDT (Geometric Dimensioning & Tolerancing) techniques to identify root causes and implement corrective actions. Lead cross-functional teams in problem-solving efforts related to quality issues, process improvements, and compliance challenges. Ensure manufacturing processes meet stringent quality standards through validation, calibration, and process verification activities. Facilitate training sessions on quality systems, regulatory compliance standards, and best practices for team members to promote a culture of continuous improvement. Qualifications Proven experience practicing in an industrial or manufacturing engineering role with a strong focus on quality assurance or control. Deep knowledge of HACCP (Hazard Analysis Critical Control Point), CGMP, Lean management principles, and Six Sigma manufacturing methodologies. Familiarity with

ISO 9001, ISO 13485

(medical devices), FDA regulations, and other regulatory/legal compliance standards relevant to manufacturing environments. Demonstrated ability to perform quality audits, inspections, and analysis skills with attention to detail. Strong understanding of quality standards in production environments including GMP and QA/QC protocols. Excellent communication skills for effective cross-functional collaboration and team leadership capabilities. Analytical mindset with proficiency in data analysis tools used for root cause analysis and process optimization. Join us to be part of a forward-thinking organization committed to excellence in manufacturing! Your expertise will help ensure our products meet the highest quality standards while supporting innovation and regulatory compliance across all facets of production.

Pay:

$85,000.00 - $110,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Tuition reimbursement Vision insurance Application Question(s):

PPAP Experience Experience:

Quality Assurance:

5 years (Preferred)

Work Location:

In person