| Software Quality Engineer || Medical device Experience Is Must || CA, MA GA (100% Onsite) at Pleasanton, California, USA |
| Email: [email protected] |
| From: Shane, Abdisolutions [email protected] Reply to: [email protected] Job Description Job Title: Software Quality Engineer Location: Pleasanton, CA / Burlington, MA (Preferred) / Atlanta, GA (100% Onsite) Job Type: Contract Job Summary: We are seeking a Software Quality Engineer with experience in the medical device industry to support quality assurance efforts, software validation, and risk assessments. The ideal candidate will have hands-on knowledge of IEC 62304 standards and familiarity with FDA regulations. This position is onsite and requires collaboration across multiple teams and departments within the organization.Key Responsibilities: Review test cases, software verification, and conduct Software Risk Assessments (SRA) or Software FMEA. Work closely with Design and Manufacturing Engineering teams to complete system/software requirements, validations, and risk analysis. Implement and maintain code control and defect tracking systems. Ensure compliance with FDA, ISO 13485, IEC 62304, and other regulatory standards. Apply Lean Manufacturing and Six Sigma methodologies for process improvements. Support Part 11 audits and maintain Quality Management Systems (QMS). Provide training for software development and validation processes. Collaborate effectively across various levels of the organization and engage in cross-functional teamwork.Qualifications: BS Degree in Engineering or a related field; Masters degree with biomedical experience is acceptable. 2-5 years of Software Quality Engineering experience (medical device experience required). Knowledge of FDA regulations, GMP, ISO 13485, IEC 62304, and IEEE 1012. Advanced skills in data analysis, report writing, and IT tools. ASQ CSQE certification preferred. Experience working in a matrixed, fast-paced environment. Strong communication, organizational, and problem-solving skills. Ability to travel internationally as needed. Note: This is a non-exempt position requiring regular attendance. The candidate must be able to work independently and collaboratively within diverse teams. Keywords: information technology California Georgia Massachusetts Software Quality Engineer || Medical device Experience Is Must || CA, MA GA (100% Onsite) [email protected] |
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| Thu Oct 31 01:46:00 UTC 2024 |