Supplier Quality Engineer/Senior Supplier Quality Engineer

Overview:

Are you looking to be part of a game-changing organization that has the potential to help cure cancer? NorthStar Medical Radioisotopes is seeking individuals with a pro-active, collaborative, can-do mindset to join our rapidly growing team.

NorthStar Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer, and customized radiopharmaceutical development services.

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 Supplier Quality Engineer/Senior Supplier Quality Engineer will contribute to 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.

Physical demands may include, but not be limited to, specific vision abilities including near vision/acuity and visual color discrimination.

The work environment may include exposure to a heated/air-conditioned indoor office / manufacturing / cleanroom setting with adequate ventilation and lighting and outdoor environments with varying temperatures. The noise level may vary from quiet to loud. Employees must be willing and able to wear various types of PPE, including, but not limited to, respirators, gloves, safety glasses, and protective clothing, as required by the job to ensure safety in potentially hazardous conditions. Specific cleanroom requirements include employees needing to inform leadership about any health condition that may have an adverse effect on products, as well as compliance with gowning protocols. This means all jewelry, including physically attached items, must not interfere with the effectiveness of personal protective equipment. In addition, all cosmetics, fragranced products (perfumes, aftershave, etc.), and nail products are prohibited, including clear nail polish, artificial nails, and nail extenders.

The company is a radiopharmaceutical manufacturer and radiation may be present in manufacturing and laboratory areas. Employees may be required to be monitored using company provided dosimetry and bioassay testing.

• Interface with QC and the 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.
• Investigate/coordinate supplier quality issues resolution with the appropriate department, including the dispositioning of non-conforming product, event, deviation, and out-of-specification reports.
• Initiate and follow up on Supplier Corrective Action Requests (SCARs) from initiation to closure.
• Provide appropriate supplier quality support during regulatory inspections, internal, and Notified Body audits
• Identify Procurement Spec Review and Change Requests.
• Work with Product Development and Manufacturing/Process Engineers to develop appropriate receiving inspection test methods, sampling plans, and acceptance criteria for new and existing components and materials, including first article inspection.
• Review and monitor strategic supplier performance, including providing trend analysis, investigation, and SCAR for monthly quality review. Liaise with internal customers to ensure effective problem resolution.
• 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.
• Assist management in implementing and maintaining a quality system that adheres to European, US, Canadian and other regulatory and Quality System requirements (ISO 13485, CFR Part 211/820, Q7)
• Provide leadership for New Product Introduction at Suppliers.
• Plan, execute, and deliver projects effectively within defined time/cost parameters.
• Ability and willingness to travel, both domestically and internationally, up to 30% of the time.

The Senior Supplier Quality Engineer will have additional responsibilities including:

• Develop and implement lean kaizen methodology to reduce waste and boost efficiency around NorthStar supply chain, incoming inspection, and in-process parts.

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.

Supplier Quality Engineer Qualifications:

Bachelors Degree in an Engineering or Scientific discipline and a minimum of three (3) years pharmaceutical industry experience in the area of supplier quality, quality assurance, quality control, supplier audit; or equivalent combination of education and experience.

Senior Supplier Quality Engineer Qualifications:

Bachelors Degree in an Engineering or Scientific discipline and a minimum of five (5) years pharmaceutical industry experience in the area of supplier quality, quality assurance, quality control, supplier audit; or equivalent combination of education and experience.

Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position. Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization, on or before the first day of employment. Under federal law, only truthful information may be provided on the Form I-9.

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.

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.