JOB DESCRIPTION
Summary/objective
The Quality Technician II 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. Working Title
Quality Technician II (Production)
Market Title
TBD
Reports To
Director of Quality
FLSA Classification
Hourly/Non-exempt
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. Required Education and Experience
•ssociate degree or equivalent in science or another related field.
• 2+ years related experience, with a solid understanding of regulatory compliance related to operations and quality procedures.
• Experience in quality assurance or quality control roles within a manufacturing or industrial environment.
• Knowledge and experience in eQMS and/or Inspection, Measuring and Test Equipment (IMTE) management. Preferred Education and Experience
• Bachelor's degree or equivalent in science, engineering, or another related field.
• 3+ years related experience, with a solid understanding of regulatory compliance related to operations and quality procedures.
• Experience in a facility with radiation regulatory requirements and or quality assurance experience with pharmaceuticals or medical devices.
• Experience with Minitab, JMP or other analytical tools.
• Experience in audits (internal, NRC, FDA, etc.).
• Knowledge of any of the following: ISO 13485, 21 CFR 820, 21 CFR 210/211, Nuclear Regulatory Commission (NRC) regulations or similar regulatory compliance experience. Physical Demands
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Use hands to finger, handle, or feel objects, tools, or controls
• Reach with hands and arms
• Climb stairs
• Walk throughout all locations of the company
• Talk and hear
• Wear safety glasses, goggles, gloves, lab coat and/or Tyvek suit.
• Occasionally lift or move office products and supplies, up to 25 pounds.
• Stand and sit for prolonged periods. Position Type/Expected Hours of Work
• Full-time position.
• The company's standard operating hours are Monday through Friday 6a - 6p with production related activities requiring 24/7/365 shifts.
• This position will have working hours during M - F and will be assigned to a production shift.
• Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role. Other duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
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