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Summary/objective The Quality Technician I plays a pivotal role in ensuring the effective, efficient, compliant, and proactive support of new product launches and the continuous quality of existing products.
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.
Specific Job Functions (Production) ?
Support product/material hold, release, disposition, and traceability assessments, and implement improvements to reduce recurring deviations. ?
Support teams throughout tolerance, nonconformances, deviations, complaints, and CAPA investigations. ?
Support teams through document revisions or change control procedures that support continuous improvement and other needs. ?
Support Quality Assurance Specialists (QAS) with completing quality checks and approvals on production records.
Competencies: ?
Embraces and models the Niowave Values of Teamwork, Courage, Integrity, and Upright Zeal. ?
Understands how to integrate into a new team/organization ? appreciates the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state. ?
Understands their own communication and learning styles, can assess others? styles, and is able to find the right path to connect the two. ?
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Demonstrates excellent organizational and analytical skills, complemented by strong computer literacy. ?
Demonstrates effective interpersonal, written, and oral communication skills. ?
Develops and maintains good relationships, gains the confidence of others and works effectively in a multidisciplinary matrix environment. ?
Resilient self-starter, who learns and acts quickly within a rapidly evolving environment.
Manufactures medical radioisotopes and superconducting accelerators for cancer treatment.
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