Quality Specialist/ Division Quality Program Lead

Job description

Work Flexibility: Onsite We are seeking a highly motivated Division Quality Program Lead to drive complex, cross-functional initiatives across our organization. In this role, you will lead end-to-end program execution—partnering with Quality, Regulatory, R&D, Supply Chain, and Operations—to ensure relabeling or other initiatives and activities are delivered on time, compliant, and operationally effective. This is a high-visibility role ideal for someone who thrives in fast-paced, regulated environments and excels at bringing structure and alignment to complex programs. What You Will Do Lead and execute end-to-end relabeling programs from planning through completion Drive alignment across cross-functional stakeholders on scope, timelines, and execution strategy Ensure compliance with quality systems, regulatory requirements, and change control processes Oversee development of key documentation (e.g., work instructions, lot records, traceability documentation) Coordinate site readiness, including materials, equipment, and trained personnel Manage logistics and inventory movement to support relabeling execution Identify and mitigate program risks, escalating issues as needed Provide clear, structured updates to leadership and key stakeholders Other responsibilities as assigned What You Need Required Qualifications Bachelor’s degree in Engineering, Life Sciences, or related field 3+ years of experience in Quality, Operations or Manufacturing Proven ability to lead cross-functional programs or projects Strong understanding of:Quality systems (e.g., NC/CAPA, change control) Regulatory environments (medical device or similar highly regulated industry) Ability to manage multiple priorities and drive execution in a dynamic environment ​Preferred Qualifications Experience with relabelling, remediation, or field action programs Experience working across global or multi-site operations Familiarity with ERP systems and product traceability ​What Makes You SuccessfulStrong leadership and influence skills across functions Clear, concise communicator (comfortable with executive updates) Highly organized with strong attention to detail Proactive problem solver who can navigate ambiguity Results-driven with a strong sense of ownership ​Why Join UsOpportunity to lead high-impact, division-level programs Visibility with cross-functional and leadership teams Ability to shape processes and drive operational improvements Collaborative, fast-paced environment with meaningful outcomes Work EnvironmentMay require travel to manufacturing or distribution sites Interaction with operational and regulated environments Travel Percentage: 10%