Mgr I, Quality Assurance

In this role you drive quality across products, processes, and systems to meet GMP, ISO, and regulatory standards. You will lead QA teams, oversee quality systems, and partner with cross-functional colleagues to ensure consistent product quality and operational excellence. You’ll steer continuous improvement, maintain audit-ready processes, and support regulatory inspections. This is a chance to shape quality culture in a mission-driven healthcare company that values courage, trust, and collaboration.

• Lead resources and coordinate activities for product inspection and regulatory compliance (DMR)
• Maintain robust identification and quarantine processes and local product retention
• Develop and evaluate Quality Sampling Plans and improvement opportunities
• Support process control implementation and participation in Operations/Management/Qa Project Reviews
• Ensure quarterly Quality System Management reviews identify productivity and quality improvements
• Oversee test method instructions during inspections and ensure material releases per specifications
• Manage resource allocation for Product Release in line with corporate objectives
• Lead investigation of Complaints and NCRs; drive corrective actions
• Facilitate long-term Quality Programs and validation activities (process, product, equipment, software)
• Ensure Incoming area compliance and create VIP/improvement plans
• Guide engineering resources for workload prioritization in quality-related areas
• Initiate or propose studies for quality/reliability of new products/processes
• Conduct Complaints Review Monthly Meetings and implement improvement actions
• Monitor product quality via quality indicators and maintain release performance
• Provide Software Validation support as needed
• Develop VIP objectives and monitor results; evaluate new projects with plant teams
• Approve and maintain manufacturing/quality SOPs and compliance
• Control SPC, Six Sigma, and CPK until final implementation
• Ensure clean room compliance with GMP, FDA, ISO and other regulatory requirements
• Support customer complaint evaluations and CAPA implementation
• Lead Non-conformance investigations and link with defect monitoring
• Collaborate with manufacturing, MIS, Process/Product, and Automation Engineering on new/improved processes
• Support FDA and Third-Party inspections
• Observe EHS requirements and hazard control; apply ergonomic principles to reduce injuries
• Lead ICare segment: BBQ alignment with Site strategy
• Align with Environmental, Health and Safety requirements

• B.S. or equivalent experience in science, Pharmacy, Industrial Engineering, or related field
• Fully bilingual (English & Spanish)
• Minimum seven years in Quality, with at least one year in a supervisory role
• ASQ CQE – preferred
• Green Belt Six Sigma and Internal/Lead Auditor – preferred
• Experience with FDA regulations, GMP, 21 CFR Part 11, CAPA, Internal Audit, and training knowledge
• Experience with software validation and quality systems

• Leadership
• Cross-functional collaboration
• Problem-solving
• CQE (ASQ)
• Six Sigma Green Belt
• CAPA and NCR handling