Purpose The Process Quality Lead position is established to enhance the Quality activities for the Business Unit, including nonconformances, complaints, audits, CAPAs, and any quality issue affecting the unit.
Responsibilities - Develop and supervise defect tracking mechanisms and coordinate improvement actions.
- Lead efforts and projects to improve quality performance for the Business Unit, including in‑process reporting, software upgrades, and more.
- Lead quality system improvements resulting from internal audits, QLT, and Quality Board issues.
- Execute quality assurance test methods and inspection procedures for raw material, work in progress, and finished product.
- Establish and maintain programs, procedures, and controls ensuring manufacturing and control of products and raw materials per procedures, specifications, medical device regulations, sterilization guidelines, and ISO standards.
- Support cost savings oppor...