Quality Assurance Engineer II

5 days ago


Allentown, Pennsylvania, United States B. Braun Medical Inc Full time
About B. Braun Medical Inc.

B. Braun Medical Inc. is a leading manufacturer of medical products and services. Our company is committed to eliminating preventable treatment errors and enhancing patient, clinician, and environmental safety.

Job Summary

We are seeking a Quality Assurance Engineer II to support new product development of active devices with embedded software (SiMD) or software as a medical device (SaMD), and supporting design changes for released products.

Key Responsibilities:
  • Provides Design Assurance Quality Engineering support to the R&D organization for new products, design modifications, and OEM customers.
  • Creates Quality and Validation plans, risk analysis, traceability matrixes, URS/FS, Design Reviews, customer interface, and follow through.
  • Responsible for data trending and analysis, issue identification and resolution.
  • Prepares reports for key quality metrics and leads continuous improvement efforts in Quality.
  • Operates in accordance with company policies, procedures, and regulatory requirements (FDA, ISO, MDD, CMDR, etc.).
Requirements:
  • Bachelor's degree required or equivalent combination of education and experience.
  • 03+ years related experience required.
  • Regular and predictable attendance.
  • Occasional business travel required.
What We Offer:

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement.

We are an equal opportunity employer and welcome applications from diverse candidates. Please visit our website to learn more about our company and our products.



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