Quality Technician

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

About the role

You thrive on details and precision, finding standardized work invigorating when deviation could cause undesirable outcomes. You enjoy analyzing processes and results to control variations and discussing improvements. You are dedicated, efficient, and contribute to a positive team environment with engaging conversation and camaraderie.

Responsibilities

• Monitor and maintain the state of inventory, quality, equipment, maintenance, calibration, and facilities to ensure compliance 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.
• 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, knows how and when to make suggestions, and uses the right pace to reach the improved future state.
• Understands your own communication and learning styles, can assess others’ styles, and finds 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.

Qualifications

• 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.).

Schedule

Full-time position. Company’s standard operating hours are Monday through Friday 6 AM – 6 PM, with production-related activities requiring 24/7/365 shifts. This position will be assigned to a shift rotation. Travel between multiple Lansing-area locations is expected.

Please provide a cover letter specifically describing the nature of your technical expertise.