Senior Supplier Quality Engineer
Are you looking to be part of something extraordinary and meaningful that is helping thousands of patients across the country every day? NorthStar Medical Radioisotopes is seeking motivated individuals like you to join our rapidly growing team in Beloit, WI. Innovative technology, Opportunities for career advancement, and competitive compensation are just the beginning at NorthStar. In addition to health and life insurance, paid holidays, and paid time off, all NorthStar employees are eligible on Day One for our annual bonus and equity incentive plans.
NorthStar develops, manufactures and distributes radioisotopes that are used daily for patients needing medically important diagnostic imaging tests. NorthStar is the first company in nearly 30 years to produce the radioisotope Mo-99 in the United States NorthStar’s processes are non-uranium based and the Mo-99 is used by radiopharmacies across the country to produce the imaging radioisotope Tc-99m. NorthStar will scale-up production over the coming months and years and intends to become the industry’s market leader. Beyond Mo-99, we have a pipeline of other novel and medically important isotopes which can further grow our business and provide development opportunities for our employees.
Working with this novel and advanced technology is challenging yet rewarding for talented individuals who want to make a difference and be part of an exciting and rapidly growing business. NorthStar’s people drive our solutions and our success, and we are committed to ensuring that we provide fulfilling work experiences and valuable development opportunities.
The Senior Supplier Quality Engineer will lead the improvement of existing supplier quality assurance processes interfacing with suppliers, internal supply chain team, QC team, manufacturing, and engineering groups to resolve problems encountered in the supply chain. Assess the capability and capacity of suppliers to perform current or potential future services. Develop training materials, performance metrics, and other resources to support improvements in supplier performance and productivity. Projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agency standards.
Duties and Responsibilities
- Develop and implement product quality plans, documents and systems by creating product and quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
- Interface with QC and Production team to identify and trend nonconforming materials.
- Develop and implement lean kaizen methodology to reduce waste and boost efficiency around NMR supply chain, incoming inspection, and in-process parts.
- Develop and implement a scorecard program to ensure adequate monitoring of supplier performance throughout NMR processes.
- Bachelor’s Degree in an Engineering or Scientific discipline and a minimum of five years pharmaceutical industry experience in the area of supplier quality, quality assurance, quality control, supplier audit; or equivalent combination of education and experience.
- Candidate must possess solid working knowledge of applicable national and international quality system regulations and standards including 21 CFR part 210/211, 21 CFR part 820, Q7A and ISO 13485.
Location – Beloit
NorthStar Medical Radioisotopes is headquartered in Beloit, Wis. This location is our primary manufacturing site and accommodates all of our corporate functions. Beloit has small city charm, with a lively and renovated downtown, yet is also close to cities such as Madison, Milwaukee, Chicago, and Rockford.
Beloit is a part of the larger South Central Wisconsin/Northern Illinois region, which offers residents and visitors alike a unique blend of urban opportunities and rural, natural beauty. The area, therefore, offers collections of natural, educational, artistic, and historical attractions alongside a wide variety of sporting and social opportunities. There are several cities and many towns within a reasonable commute of Beloit, which offer a wide choice of residential styles and a large number of school district choices for those considering relocation.
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.
Senior Supplier Quality Engineer – 1800 Gateway Blvd Beloit, WI 53511