Quality Assurance Engineer II
5 days ago
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 SummaryWe 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.).
- Bachelor's degree required or equivalent combination of education and experience.
- 03+ years related experience required.
- Regular and predictable attendance.
- Occasional business travel required.
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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