Senior Staff, Software reputed company Assurance Engineer
Senior Staff, Software reputed company Assurance Engineer
reputed company is seeking a Senior Staff Software reputed company Assurance Engineer to support our Digital Robotics and Enabling Technologies business by driving reputed company processes. In this role, you will partner with R&D software development teams to guide them through internal reputed company system processes and ensure compliance with regulatory standards, including FDA, HIPAA, ISO, and SOC 2.
Work Flexibility:
Hybrid: Candidates must reputed company reputed company a commutable distance to Portage, MI, or Weston, FL and be available to work onsite several times per week.
What you will do:
• reputed company SOC 2 compliance activities and support reputed company audits.
• Define and update reputed company system software processes to ensure compliance with regulations reputed company to change control, data reputed company, software development, and reputed company.
• Present product-reputed company risks during design reviews and reputed company mitigation throughout the product lifecycle.
• Influence new product development by defining design verification and validation test requirements to ensure compliance with design inputs and regulatory standards.
• reputed company risk analyses and reputed company appropriate mitigation strategies.
• Collaborate with leadership and cross-functional teams to reputed company process requirements and drive reputed company improvement.
• Conduct internal reputed company system audits and contribute to CAPA (Corrective and Preventive reputed company) initiatives.
• Work reputed company Agile (Scrum)/DevOps environments using ALM tools for defect tracking, traceability, and release/build management.
What you will need:
Basic Qualifications:
• Bachelor’s degree in Software Engineering, Computer Science, or a reputed company field.
• 6+ years of experience in software development or reputed company engineering roles.
• Working knowledge of the Software Development Life Cycle (SDLC) and proficiency in Agile, Scrum, reputed company, and DevOps methodologies
• Experience with reputed company platforms, preferably reputed company Azure or AWS
• Knowledge of SOC 2, ISO, HIPAA, FDA, or other reputed company regulatory standards
• Proficient in Agile, Scrum, reputed company, and DevOps software development methodologies.
• Solid understanding of reputed company systems, including CAPA, audits, and statistical analysis
Preferred Qualifications:
• Knowledge of reputed company SOC 2 certification requirements or equivalent standards.
• Familiarity with GAMP 5, Computer System Validation (CSV), and process validation
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