Quality Assurance Engineer

GG BRANDS COMPANY•Sharonville, OH

11d•Onsite

About The Position

The Quality Assurance Engineer supports product development, manufacturing, and release activities by establishing, implementing, and monitoring processes and procedures that ensure compliance with company policies and applicable regulations and standards, including FDA, ISO, and OSHA. This role leads continuous improvement initiatives, oversees key quality systems, and collaborates cross-functionally to ensure products consistently meet specifications as well as customer and consumer expectations.

Requirements

Bachelor’s degree in related field or equivalent work experience
Five years of experience in an FDA GMP (personal care products, medical devices or food) manufacturing environment, in a Quality role
Working knowledge of ISO 22716 and FDA 21 CFR 210/211 regulations
ASQ Certification (CQE or CQA)
Proficient with Microsoft Office
Formal training in auditing
Strong communication and collaboration skills
Self-motivated
Flexibility
Excellent problem-solving skills

Responsibilities

Identify bottlenecks, inefficiencies, inconsistencies or risks in quality/production/testing processes and propose solutions.
Conduct annual internal audits and periodic walk-through audits on company and department requirements and cGMPs.
Establish and lead cross functional teams to streamline processes, correct errors and implement improvements.
Develop or modify Standard Operating Procedures.
Develop and conduct quality system training.
Conduct root cause analysis investigations to determine failure points and recommend/help drive corrective actions to resolve defects and prevent recurrence.
Manage deviations and conduct effectiveness checks on completed non-conforming product reports.
Review and approved batch records, deviations and change controls.
Manage the calibration program and maintain records of test results, defects and corrective actions.
Conduct and document consumer complaint investigations and collaborate with cross functional departments and contract manufacturers on next steps.
Track key Quality KPIs like defect rate, first-pass yield, and cost of poor quality.
Participate in meetings to represent quality and negotiate solutions when quality expectations and production goals conflict.
Any other duties as assigned by manager.