Essential Functions - Monitor and maintain the state of inventory, quality, equipment, maintenance, calibration and facilities and ensure they comply with QS and cGMP requirements.
- Drive quality and compliance, adhering to all Quality Systems documentation requirements and establishing/supporting plans to exceed Niowave's goals for Quality, including Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD), and financial objectives.
- Support internal and external audits.
- Support validation of test methods, monitoring processes, and equipment.
- Support production teams in product/material hold, release, disposition, and traceability assessments, and implement improvements to reduce recurring deviations that lead to rework or scrap.
- Support new product introduction (NPI) quality activities including prototype testing, process validation, and technology transfer ensure successful product launches.
- Collaborate with cross-functional teams to support and solve production and quality challenges.
- Collect, monitor, analyze and communicate data to provide insight on quality metrics set by the management team.
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