FirstBank Jobs

JOB REQUIREMENTS: Job TitleQuality Analyst Requisition JR000014219 Quality Analyst (Open) Location CC-Madison - USA503 Additional Locations Madison, WI Job Description The Quality Analyst ensures that all materials, activities, processes, and specified conditions involved in daily device manufacturing, processing, and packaging meet current GMP standards and comply with relevant procedures and standards to maintain product quality integrity. Additionally, the Quality Analyst manages nonconforming material reports, plans material review board meetings, and oversees the status of quarantined and scrapped materials. Essential Functions Collaborating regularly with representatives from Quality, Purchasing, Engineering, and Manufacturing to resolve nonconforming material reports. Tracking and trending nonconforming material reports to ensure quality processes remain controlled. Analyzing failure modes and performing statistical analysis of nonconforming parts. Reviewing nonconforming material reports, addressing discrepancies, and escalating issues to management as necessary. Preparing for material review board meetings and acting as a backup Quality representative during these meetings. Ensuring all nonconforming parts are properly controlled using the on-site quarantine cage. Updating the status of all nonconforming parts appropriately within SAP. Developing, implementing, and maintaining QA procedures, standards, and controls. Supporting Quality through occasional investigations of nonconformance and assisting with corrective and preventive actions associated with the QA unit. Performing internal and external audits of systems and suppliers. Assisting with site audit support. Managing documentation as required. Supporting other Quality System functions. Assisting with the completion of supplier corrective action reports. Minimum Requirements Associates degree with 3+ years experience managing complaints and investigations with metrics in pharma/medical device industry - OR - Bachelor\'s Degree with 1+ years Knowledge of FDA CFR 820 and ISO 13485 requirements medical device manufacturing High level of motivation; ability to work independently. Ability to communicate well,... For full info follow application link. Mallinckrodt Pharmaceuticals provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetics. In addition to federal law requirements, Mallinckrodt Pharmaceuticals complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/B1925E39CB5E4C86