Quality Engineer

Are you looking to be part of a game-changing organization that is helping thousands of patients across the country every day? NorthStar Medical Radioisotopes is seeking individuals with a pro-active, collaborative, can-do mindset to join our rapidly growing team in Madison, WI or Beloit, WI.

NorthStar develops, manufactures, and distributes radioisotopes used daily for patients needing medically important diagnostic imaging tests. Using novel and advanced technologies, NorthStar will scale-up production over the coming months and years and intends to become the industry’s market leader.

Innovative technology, opportunities for career advancement, and competitive compensation are just the beginning. NorthStar offers health and life insurance, 401K match, paid holidays, and paid time off, and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans.

The Quality Engineer will be responsible to support the planning, management, and execution of the start-up, commissioning, and validation of new radionuclidic separation instruments, radiochemical manufacturing/filling processes, and assist in other projects. They will review and approve Validation Protocols, such as Product Design, Installation, and Operational, Validation Plans, and Protocols.

Duties and Responsibilities

  • Act as a quality assurance representative on cross-functional product development teams.
  • Consistently follows program status, participates in cross-functional decision making, and insures team decisions are consistent with regulatory and quality system requirements
  • Proactively provides input, guidance, as needed on the development of specifications, project plans, test protocols/reports, etc.
  • Is primary quality approver of product development team deliverables for Phase 1 and Phase 2, ensuring documentation meets regulatory and internal product development process requirements.
  • Participates as a key team member in risk management activities including PFMEA, DFMEA, risk mitigations, and directs subsequent integration into Product/Process Risk & Hazard Analysis.

A Bachelor’s Degree in Physical Sciences and one to three years experience in the pharmaceutical/medical device industry and in quality assurance and product development support; or equivalent combination of education and experience. Sound knowledge of applicable portions of agency guidance, and regulations (21CFR Part 210/211/820, ISO 13485, and ICH Q7).

Madison isn’t just the “Capital City,” it also houses NorthStar Medical Radioisotopes’ Research and Development facilities.

The Madison region is a place where dynamic, talented, innovative and hardworking people want to be. We know this because the region is growing at a faster rate than the state and the nation. Madison, Wis. was named first on Livability’s top 100 places to live in 2014.

If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.

NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law.

Quality Engineer – Madison, WI or 1800 Gateway Blvd. Beloit, WI



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