Quality Technician

Niowave; Lansing (MI); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading medical isotope company in Lansing is seeking a Quality Technician to ensure compliance with quality standards and assist in production processes. The role requires attention to detail, strong analytical and problem-solving skills, and at least 3 years of relevant experience. Candidates should hold a degree in a related field and have a solid understanding of quality assurance in manufacturing. This full-time position involves a shift rotation and offers an engaging work environment where teamwork and integrity are valued.

Qualifications

• 3+ years related experience in quality assurance or quality control.
• Solid understanding of regulatory compliance in manufacturing.
• Ability to analyze data and provide insights on quality metrics.

Responsibilities

• Monitor and maintain inventory, quality, equipment compliance.
• Drive quality and compliance, adhering to quality system requirements.
• Support validation of test methods and processes.

Skills

Attention to detail

Analytical skills

Problem-solving

Organizational skills

Teamwork

Education

Associate or bachelor’s degree in science or related field

Bachelor’s degree preferred

Tools

Electronic quality management systems

Minitab

JMP or analytical tool software

Job description

If you’re ready to make a meaningful, life-saving contribution, your journey starts here.

Join a diverse, purpose-driven team where scientists, engineers, technicians, and other professionals collaborate on work directly impacting patients and are guided by shared values of Teamwork, Integrity, Courage, and Upright Zeal.

Niowave is a dedicated equal opportunity employer that embraces diversity and fosters an inclusive workplace. Our employment selection process and all other employment decisions are free from discrimination based on factors such as race, color, religion, national origin, gender, disability, age, or any other characteristic prohibited by law.

Position:Quality Technician

Location: Lansing, MI

Job Id:314

# of Openings:1

Quality Technician

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.

What you can expect to work on…

• 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.

What you need to succeed…

• 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
• Excellent analytical skills and problem-solving skills with the ability to critically interpret and use data to manage risk.

Great to have…

• 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.

Other things to note…

• Full-time position.
• Company’s standard operating hours are Monday thru Friday 6a – 6p with production related activities requiring 24/7/365 shifts.
• This position will be assigned to a shift rotation.
• Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role.

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