Job Description
Job Description This role is responsible for building and stabilizing quality systems across a manufacturing site and laboratory that currently lacks strong, consistent processes. We need a seasoned quality professional who can drive change, communicate clearly at all levels, and put structure in place — not a first‑time manager. The lab will report into this role, along with a Quality Engineer. This person will focus on improving cycle times, validation rigor, audit readiness, and overall quality performance. What You’ll Do Put quality systems and processes in place across operations and the lab Improve test analysis timelines, product qualification, and validation efficiency Drive lean quality practices to reduce waste and working capital Review staffing and processes in the lab and recommend improvements Benchmark sister sites and implement best practices locally Own validation activities (IQ/OQ/PQ, process, cleaning, software validation) Lead root cause analysis, CAPAs, and change control Strengthen and maintain the QMS (ISO‑aligned) Lead and support internal, customer, and third‑party audits Partner closely with Manufacturing to improve process stability Act as the site quality SME and leader for change We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by app