Quality Technician

Niowave Inc.•Lansing, MI

4d•Onsite

About The Position

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. 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. Monitor and maintain the state of inventory, quality, equipment, maintenance, calibration, and facilities to ensure they comply with QS and cGMP requirements. Drive quality and compliance, adhering to all Quality System documentation requirements and establishing/supporting plans to exceed Niowave’s goals for Quality, Safety, Compliance, 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 to 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. Support product/material hold, release, disposition, and traceability assessments. Implement improvements to reduce recurring deviating events. Perform tolerance, nonconformances, deviations, complaints, and CAPA investigations. Execute document revisions and change control procedures. Perform inspection and disposition of regulated incoming materials. Perform data collection and analysis utilizing Environmental Monitoring equipment. Support Quality Assurance Specialists (QAS) with completing quality checks and approvals on production records.

Requirements

Associate or bachelor’s degree or equivalent in science or other related field.
3+ 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.
Experience with electronic quality management systems.
Embraces & 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 your own communication and learning styles, can assess others’ styles, and is able to find the right path to connect the two.
Resilient self-starter, who learns and acts quickly within a rapidly evolving environment.
Demonstrates excellent organizational and project management skills for self and teams
Strong computer literacy (Microsoft Office, Adobe)
Excellent analytical skills and problem-solving skills with the ability to critically interpret and use data to manage risk.

Nice To Haves

Bachelor’s degree or equivalent in science, engineering, or related field.
5+ years relevant 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 role in the pharmaceutical or medical device industry.
Experience with Minitab, JMP, or analytical tool software.
Experience in audits (internal, NRC, FDA, etc.)

Responsibilities

Monitor and maintain the state of inventory, quality, equipment, maintenance, calibration, and facilities to ensure they comply with QS and cGMP requirements.
Drive quality and compliance, adhering to all Quality System documentation requirements and establishing/supporting plans to exceed Niowave’s goals for Quality, Safety, Compliance, 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 to 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.
Support product/material hold, release, disposition, and traceability assessments.
Implement improvements to reduce recurring deviating events.
Perform tolerance, nonconformances, deviations, complaints, and CAPA investigations.
Execute document revisions and change control procedures.
Perform inspection and disposition of regulated incoming materials.
Perform data collection and analysis utilizing Environmental Monitoring equipment.
Support Quality Assurance Specialists (QAS) with completing quality checks and approvals on production records.