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Quality / Regulatory Technician III / IV
$64k-79k (estimate)
Full Time
2 Months Ago
Niowave is Hiring a Quality / Regulatory Technician III / IV Near Lansing, MI
Quality / Regulatory Technician 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. You are someone who lives and breathes keeping things organized and supporting others in being successful. 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’ll make an impact…
The Regulatory/Quality Technician III/IV plays a pivotal role in ensuring the effective, efficient, and compliant maintenance, tracking, and recording in support of Regulatory requirements in the management of radioactive materials and product development of medical radioisotopes for cancer treatment.
What you will work on…
- Responsible for the monitoring, tracking, and maintaining of Nuclear Regulatory Commission (NRC) and State of Michigan documents, binders, etc. used for operations and accessed during audits.
- Tracks the training completion for radiation safety, emergency plan, laboratory, etc. within Master Control and communicates staff member completion for key card access.
- Coordinates radiation safety training sessions and other training sessions.
- 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 participate in quality improvement initiatives and projects.
- Support quality reviews and audits (internal and external) by evaluating data, preparing reports to verify regulatory compliance, managing documents, identifying deviations and recommending opportunities for improvement. Audits could both for Quality and Regulatory (Radiation Safety/NRC).
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 are able to 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.
Regulatory/Quality Technician III Qualifications
- Associates or Bachelor degree in science or other related field or equivalent experience.
- 4 years related experience, with a solid understanding of regulatory compliance related to operations and maintenance procedures.
Regulatory/Quality Technician IV Qualifications
- Associates or Bachelor degree in science or other related field or equivalent experience.
- 6 years related experience, with a solid understanding of regulatory compliance related to operations and maintenance procedures.
Great to have…
- Knowledge of ISO 13485, 21 CFR 820, 21 CFR 210/211, and Nuclear Regulatory Commission (NRC) regulations.
- Knowledge in Inspection, Measuring and Test Equipment (IMTE) management.
- Proficiency in applying logic and reasoning to solve complex problems, making timely, high-quality decisions utilizing Six Sigma Root Cause Analysis (RCA) tools.
- Adept at utilizing quality methods, tools, and techniques to support an environment aligned with organizational needs.
- Software proficiency: eQMS and Gage Management software, Minitab.
- Experience in audits (internal, NRC, FDA, etc.).
Other things to note…
Position Type/Expected Hours of Work
- Full-Time position.
- 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 meet with managers and employees working outside of the standards operating hours as needed.
- Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role.
Job Summary
JOB TYPE
Full Time
SALARY
$64k-79k (estimate)
POST DATE
03/24/2024
EXPIRATION DATE
05/23/2024
WEBSITE
niowaveinc.com
HEADQUARTERS
Lansing, MI
SIZE
50 - 100
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