Job Posting for Quality Technician at Niowave Inc.

Quality Technician I/II/III

Who we are…

We are a group of scientists, engineers, designers, technicians, and many others who are dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We also enjoy darts, cornhole, ping-pong, take-out for group lunches, chili cook-offs, and other fun events that makes our company a community where we make a life, not just a living.

Why patients need you…

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to our partners and patients. Our science and risk-based compliant quality culture is innovative and partner oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients.

Who you are…

You love details and precision. You find standardized work in which deviation could cause an undesirable outcome to be invigorating. Analyzing processes and results to control variations and discussing when improvements would best be introduced is a desirable pastime. Words that describe you are dedicated, efficient, and someone who contributes to making the workday fly by with engaging conversation and team comradery.

What you can expect to work on…

You’ll provide instrumental support within the quality team and throughout the company to ensure timely product and compliance support.

What you need to succeed…

Excellent communication and interpersonal skills – you know how to develop & maintain strong relationships with all levels/teams of the organization. Understand how to integrate into a new team/organization – you appreciate 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. Understand your own communication and learning styles, assess other styles, and can find the right path to connect the two. Exceptional technology skills – you find working with any software very comfortable, and you easily adapt to new products.

What You Will Achieve…

The Quality Technician ensures a compliant state of inventory, quality, equipment, and facilities in our new manufacturing facility in adherence with cGMP requirements, Quality Standards, and other regulatory requirements. This position is part of a strong and growing team launching first of its kind products to accelerate the fight against cancer.

Essential functions

Utilize advanced quality tools to drive improvements, encompassing process flowcharting, gauge repeatability and reproducibility, and basic data analysis.
Monitor manufacturing processes and products, for adherence to both company and regulatory standards, and actively participating in quality improvement initiatives and projects.
Support quality reviews and audits (internal and external) by evaluating data, preparing reports to verify regulatory compliance, identifying deviations and recommending opportunities for improvement.
Support validation of test methods, processes, and equipment.
Support NPI quality activities including prototype testing, process validation, and technology transfer ensure successful product launches.
Support IMTE (gage) calibration, management, reporting and potential correspondence with vendors for repairs or replacement.
Participate in pre- and post-production reviews, providing valuable quality and insights.
Collect and analyze data to provide insight on quality metrics set by the management team.
Lead or support teams through IMTE Out of Tolerance investigations, NCMR, complaints, and CAPA. Perform Root Cause Analysis (RCA) utilizing common Six Sigma tools.
Collaborate with cross-functional teams to solve production and quality challenges.
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 process or document change efforts to enhance internal rework and scrap processes for reduction in deviations.
Monitor internal and external quality metrics and proactively resolve issues related to product characteristics, features, and associated documentation supporting quarterly monitoring and management reviews.
Support a positive business culture that aligns with our values and leadership competencies.

Competencies

Preferably, knowledge of ISO 13485, 21 CFR 820, 21 CFR 210/211 knowledge is beneficial.
Knowledge in IMTE management.
Proficiency in applying logic and reasoning to solve complex problems, making timely, high-quality decisions utilizing Six Sigma RCA tools.
Adept at utilizing quality methods, tools, and techniques to support an environment aligned with organizational needs.
Skilled in conducting measurement correlation studies and generating final inspection information.
Ability to interpret blueprint dimensions and specifications for inspection purposes.
Ability to determine measurement method and tools needed for inspection purposes.
Ability to effectively manage and prioritize numerous tasks and responsibilities.
Excellent organizational skills, complemented by strong computer literacy.
Effective interpersonal communication skills, bolstered by confident decision-making abilities.
eQMS and Gage Management software knowledge is preferred.
Minitab knowledge is preferred.
MS Office experience is preferred.

Education and experience

Quality Technician I - Associates degree (A.A.) from two-year college or technical school; or six months to one year related experience and/or training.
Quality Technician II - Associates degree (A.A.) from two-year college or technical school and/or two (2) years’ experience in a regulated industry, preferably quality assurance in pharmaceuticals or medical device.
Quality Technician III - Associates degree (A.A.) from two-year college or technical school and minimum of five (5) years’ experience in a regulated industry, preferably quality assurance in pharmaceuticals or medical devices.
Preferred: Quality or Regulatory certifications

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment.

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.

While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 20 pounds.

Position Type/Expected Hours of Work

This is a full-time position. Days of work are typically Monday through Friday, 8 a.m. to 5 p.m. Occasional early or late hours may be needed.

Travel

Travel is primarily local during the business day between the company’s two locations.

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Quality Technician

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