Manager, Quality Engineering Product Surveillance

Role: Lead Quality Engineering Product Surveillance to enhance product quality, investigate issues, and drive continuous improvement within a biopharma manufacturing context. Responsibilities include managing complaint handling systems, leading cross-functional investigations, implementing CAPA, analyzing complaint metrics, and fostering a culture of accountability and operational excellence. The role emphasizes collaboration with Engineering, Manufacturing, and Customer teams to resolve complex quality challenges and maintain ISO 9001 compliance. Requirements: Bachelor's in Engineering, Life Sciences, or related field; 7+ years in Quality Assurance with at least 3 years in leadership; deep knowledge of ISO 9001, complaint management, root cause analysis, and QMS; experience with electronic quality management systems, audits, and cross-functional stakeholder engagement. Preferred: proficiency with business software including Salesforce; strong communication and technical writing skills. High-value specifics: focus on complaint investigation, CAPA, root cause analysis, and continuous improvement within a biopharma production setting, with an emphasis on customer-centric quality resolution. Work setup and travel details are not specified.