Supplier 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 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.
This position will contribute to 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
- Interface with QC and Production team to identify and trend nonconforming materials.
- Collaborate with internal departments to lead and execute Production Parts Approval activities.
- Develop and implement a scorecard program to ensure adequate monitoring of supplier performance throughout NMR processes.
- Support supplier quality management programs such as supplier selection and qualification.
- Act as lead auditor or auditor during supplier audits.
- Interface with product development team to ensure appropriate certification of parts/services used in the product development process.
Bachelor’s Degree in an Engineering or Scientific discipline and a minimum of three to five years of 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.
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.
Supplier Quality Engineer – 1800 Gateway Blvd. Beloit, WI 53511