Quality Assurance Engineer over Medical - Position will require relocation to Bowling Green, KY Ibryo Recruiting Firm Cincinnati, OH Job Details Full-time $110,000 - $125,000 a year 1 day ago Benefits Relocation assistance Health insurance 401(k) Qualifications Manufacturing facility experience Bachelor's degree Industrial engineering Training & development Root cause analysis Full Job Description Job Summary We are seeking a dedicated and detail-oriented Quality Assurance Engineer specializing in medical manufacturing to join our team. This role requires relocation to Bowling Green, KY, and offers an exciting opportunity to contribute to the development and maintenance of high-quality medical products. The ideal candidate will oversee quality assurance processes, ensure compliance with regulatory standards, and support continuous improvement initiatives within a manufacturing environment. Your expertise will help uphold the integrity of our products, ensuring they meet stringent quality and safety standards required in the medical industry.

Key Responsibilities:

Develop, implement, and maintain quality assurance systems aligned with industry standards such as

ISO 9001, ISO

13485, GMP, and FDA regulations Conduct comprehensive quality audits across production processes to verify adherence to quality standards and regulatory requirements Lead investigations into product non-conformities, analyze root causes, and implement corrective and preventive actions Perform quality inspections and control checks throughout the manufacturing cycle to ensure product integrity Collaborate with cross-functional teams including manufacturing, engineering, and regulatory affairs to enhance quality systems Facilitate training sessions on quality standards like HACCP, CGMP, Lean management, Six Sigma, and GD&T for staff Support regulatory compliance efforts by preparing documentation for audits and certifications Monitor key performance indicators related to quality metrics and drive continuous improvement initiatives Lead or participate in internal and external quality audits to ensure ongoing compliance with industry standards Manage documentation related to quality processes, deviations, CAPAs (Corrective Action Preventive Action), and validation activities Qualifications Bachelor's degree in Industrial Engineering, Manufacturing Engineering, Quality Management, or a related field Proven experience practicing in an industrial or manufacturing engineering role within the medical device or pharmaceutical sector Extensive knowledge of quality standards such as

ISO 9001, ISO 13485, GMP, CGMP, FDA

regulations, and Lean management principles Strong understanding of quality control techniques including Gage R&R (Repeatability & Reproducibility), GD&T (Geometric Dimensioning & Tolerancing), and statistical analysis methods like Six Sigma Experience conducting quality audits and ensuring compliance with regulatory/legal standards in production environments Familiarity with QA/QC procedures related to medical manufacturing processes Excellent analysis skills with the ability to identify issues quickly and develop effective solutions Strong team leadership capabilities combined with cross-functional communication skills Project management experience is preferred for coordinating improvement initiatives If you are committed to advancing product excellence through rigorous quality assurance practices within a dynamic medical manufacturing environment, we encourage you to apply. Join us in delivering safe and reliable medical products that make a difference worldwide.

Pay:

$110,000.00 - $125,000.00 per year

Benefits:

401(k) Health insurance Relocation assistance

Work Location:

In person