Supplier Quality Engineer

Company Info
SHINE Medical Technologies
Janesville, WI, United States

Phone: 6082101071
Web Site: www.shinemed.com

Company Profile
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Title:

Supplier Quality Engineer

Location:

Janesville, WI 

Job ID:

64897
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Job Description:

SHINE is immediately seeking a Supplier Quality Engineer to help ensure that SHINE meets regulatory/quality requirements for contracted suppliers.  The Supplier Quality Engineer will have strong supplier quality auditing skills and a current nuclear Lead Auditor certification. The position will report directly to the Nuclear QA Manager.  

Duties and Responsibilities:

Specific duties and responsibilities include, but are not limited to:

  • Primary responsibility for evaluation and qualification of suppliers
  • Maintain approved suppliers that provide items and services to SHINE
  • Perform various assessments/audits and assist in the conduct of QA/QC oversight activities
  • Developing and facilitating changes to SOPs, policies, training materials, and other documents of a technical or quality discipline
  • Mentoring co-workers and internal customers on quality and regulatory requirements (e.g., NRC, cGMP, GLPs), SOPs, and guidance documents, as assigned
  • Preparing and revising submissions to various regulatory agencies and/or customers in accordance with procedures
  • Following relevant procedures and instructional documentation, and applying regulatory/quality guidelines/requirements when performing documentation assessments
  • Performing/Supporting internal quality system assessments as an assessment team member
  • Executing/Supporting annual assessment schedule events as assigned
  • Developing assessment plans, assisting with the performance and reporting of assessment results
  • Preparing status of findings and corrective actions
  • Providing a support role as QA representative during regulatory agency assessments
  • Helping develop QA training requirements for current and new employees
  • Assisting in the maintenance of electronic and hard copy records

Requirements:

  • A Bachelor’s degree in engineering or a scientific discipline is highly preferred; advanced degrees can reduce experience requirements for advance levels
  • Minimum of five (5) years of experience in nuclear quality assurance are preferred.
  • Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or other Quality certification a plus (e.g.: NQA Lead Auditor, DOE Lead Assessor)
  • Work independently and apply the critical thinking necessary to draw conclusions from a variety of sources.
  • Must be able to communicate effectively with all levels within the organization, as well as interface with clients, contractors, suppliers, and Nuclear Regulatory Commission (NRC) personnel
  • Experience with welded metal fabrication and/or power-related construction activities is desired
  • Attention to detail with an ability to identify, document and ensure correction of errors/inconsistencies/problems
  • Technical understanding of nuclear facility principles and construction and/or operations preferred
  • Ability to multitask and work within a fast-paced dynamic team environment
  • Demonstrated customer/client focus

SHINE Medical Technologies is a nuclear technology company committed to improving the lives of patients around the world. The company is focused initially on the commercialization of medical isotopes. Molybdenum-99 is a diagnostic isotope used to diagnose heart disease, cancer and other diseases. Lutetium-177 is a therapeutic isotope could revolutionize cancer treatment. SHINE’s unique expertise and experience have created isotope production processes that not only will deliver products that help physicians and patients, they will solve critical supply chain problems in the United States, Europe and other global markets. SHINE’s nuclear technology is part of its long-term growth strategy to solve some of humanity’s biggest problems, including the generation of carbon-free energy from nuclear fusion. For more information, please visit our website at www.shinemed.com.


Eligibility for employment is conditioned on the applicant’s ability to qualify for access to information subject to U.S. Export Controls.  Additionally, applicant’s eligibility may be conditioned based upon meeting the Nuclear Regulatory Commission requirements for access to Safeguards Information, which typically requires a pre-employment drug screen, fingerprinting and criminal background check.

SHINE values diversity in all its forms as a critical component of innovation, which is fundamental to our success. Every member of the SHINE community benefits from the talents and experiences of our peers, from the mutual respect we exercise, and from the responsibility we take for our actions.