Quality Technician (Production) III / IV
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.
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.
How you make an impact…
You’ll provide instrumental support within the quality team and throughout the company to ensure timely product and compliance support. 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.
What you will achieve…
- 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 new product introduction (NPI) quality activities including prototype testing, process validation, and technology transfer ensure successful product launches.
- Lead and participate in product/material hold, release, disposition, and traceability assessments, and implement improvements to reduce recurring deviations that lead to rework or scrap.
- Lead or support teams through out of tolerance, nonconformances, complaints, and CAPA investigations.
- Lead or support teams through change control that support continuous improvement and other needs.
- Lead or support Quality Assurance (QA) with completing quality checks and approvals on production records.
What you need to succeed…
- Associates or Bachelor degree or equivalent in science or other related field.
- 5+ 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, Inspection, Measuring and Test Equipment (IMTE) management systems, statistical process control (SPC), and root cause analysis methodologies (Six Sigma RCA).
- 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.
Great to have…
- Certification in quality management or related field (e.g., Certified Quality Technician/Engineer, Six Sigma).
- 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 ISO 13485, 21 CFR 820, 21 CFR 210/211, and Nuclear Regulatory Commission (NRC) regulations or similar regulatory compliance experience.
Work Environment
- The company’s standard operating hours are Monday thru Friday 6a – 6p with production related activities requiring 24/7/365 shifts.
- This position will have regular working hours during M – F with an expectation of adjusting to operational commitments as needed.
- Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role.
- While performing the duties of this job, the employee is occasionally required to:
- 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, googles, gloves, lab coat and/or Tyvek suit.
- The employee must occasionally lift or move office products and supplies, up to 25 pounds. This position may stand and sit for prolonged periods.
Please provide a cover letter specifically describing the nature of your interest & expertise.
