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.
• 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.
|