Quality Risk Management Specialist

Job Title: Quality Risk Management AnalystLocation: Bridgeton, MO (St. Louis) - Fully onsiteDuration: 3 months, with the possibility of extensionEmployment Type: W2C2C1099Local candidates are preferred, and only U.S. citizens are eligible.Key Responsibilities:- Identify and evaluate quality risks in manufacturing, product development, and supply chain.- Develop and implement risk mitigation strategies.- Document risk assessment results and ensure compliance with industry standards (ISO, FDA, GMP).- Support continuous improvement initiatives and facilitate CAPA processes.- Collaborate with cross-functional teams and provide training on risk management tools.- Prepare and present risk assessment findings to management.Qualifications:- Education: Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or Quality Management.- Experience: 5-10 years in quality risk assessments, preferably in regulated industries (pharmaceuticals, medical devices, food safety).Skills: - Strong analytical and problem-solving abilities.- Familiarity with risk assessment tools (FMEA, FTA).- Proficient in quality management systems and regulatory frameworks.- Excellent communication and organizational skills.- Experience with regulatory audits (FDA, ISO 13485) is a plus.- Exp of tracking the assessments through the entire process- Manufacturing experience.Preferred:- Microbiology background- Knowledge of statistical process control (SPC)- Proficiency in risk management software (e.g., Windchill, TrackWise)**Note:** Candidates with a microbiology background and extensive experience in quality risk assessments are highly preferred.

Created: 2025-02-22