Senior Quality Systems Specialist

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: Senior Quality Systems Specialist

Location: Lansing, MI

Job : 330

# of Openings: 1

We are a team of scientists, engineers, technicians, and innovators dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We believe in building an environment where collaboration, curiosity, and camaraderie thrive. We also enjoy darts, cornhole, ping-pong, chili cook-offs, and other fun events that make our company a community where we make a life, not just a living.

You are someone who genuinely cares about doing things the right way and finds purpose in work that requires integrity, structure, and trust. Quality and compliance resonate with you because you enjoy bringing clarity to complexity and creating systems that people can rely on. You are naturally collaborative and value building strong relationships, listening to different perspectives, and helping teams align in practical and meaningful ways.

You take pride in being dependable and thoughtful, approaching challenges with sound judgment and a steady, solutions-oriented mindset. You are motivated by continuous improvement and enjoy helping others learn, grow, and succeed. Words that describe you include thoughtful, collaborative, principled, dependable, and grounded.

The Senior Specialist is a highly experienced subject matter expert who leads strategic Quality Systems initiatives, supports audit and inspection strategy, and influences organizational compliance direction. This role serves as a key advisor across functions, mentors team members, and drives continuous improvement and regulatory excellence. This role serves as a trusted collaborator to leadership, assists in guiding team direction, and leads efforts in high-visibility regulatory environments.

• Leads, configures, and optimizes QS software systems, ensuring proper workflows, validations, and integrations for deviations, CAPAs, change control, and document control modules
• Serves as the site-level subject matter expert for regulatory inspections and audits
• Serves as the primary implementer for resolutions to audit and inspection findings, including:
  • Document revisions and creation of SOPs and QS procedures
  • Updating forms, templates, and training materials
  • Ensuring proper execution of CAPAs arising from audits
• Leads or supports front room and backroom audit activities, ensuring timely and compliant responses; implements and maintains a robust audit program
• Conducts complex investigations, root cause analyses, and effectiveness checks
• Mentors and coaches Quality Systems Specialists and technical staff to develop capabilities across the organization
• Leads cross-functional initiatives, influencing stakeholders and building consensus on quality-related decisions
• Drives enterprise-level continuous improvement and system optimization

• Bachelor’s degree in Life Sciences (biology, chemistry, biochemistry, Engineering (chemical, biomedical, industrial), or related field
• 10+ years of GMP/Quality…