Sai Krishna M.

About Sai Krishna M.

I work at the intersection of risk, regulation, and human behavior, helping organizations make better decisions in complex, regulated environments.I specialize in designing CAPA systems that actually function—rooted in true cause, implemented with accountability, and evaluated for real effectiveness—not just regulatory closure.My strength is translating complexity into action while aligning patient safety, business reality, and executive intent. I lead quietly, prioritize risk over noise, and build resilient systems that don’t rely on heroics to succeed.

Experience

1. Senior Quality Engineer

   Getinge

   May 2024 — Present · Wayne, NJ, US

   Supporting Risk management remediation efforts to improve defect detection of product in the field. Conducting continuous monitoring of Hazard occurrence rate and benefit risk assessment. Guide and support CAPA owners to meet targets and ensure timely, effective resolution of non-conformities. Ensure CAPA execution aligns with consent decree requirements and global regulatory expectations, including FDA and international standards. Provide strategic support for CE Mark reinstatement efforts by strengthening compliance and risk management processes. Prepare for and support regulatory audits, including TUV SUD and Proveritas, ensuring transparency and readiness. Enhance quality and compliance processes through collaboration with cross-functional teams, driving continuous improvement. Assist in usability studies and support validation & verification (V&V) test protocol development to ensure product safety and effectiveness.Draft and review technical documentation, including requirements and risk assessments, to support design control activities. Contribute to Design History File (DHF) remediation projects, ensuring alignment with regulatory and quality expectations. Apply deep expertise in CAPA methodologies, root cause analysis, and risk-based decision-making. Leverage experience with audits to strengthen regulatory compliance. Maintain a strong working knowledge of design controls and compliance standards (IEC 60601, ISO 14971, EU MDR and ISO 13485) in the medical device industry. Collaborate effectively across teams, utilizing strong communication and organizational skills to align stakeholders and drive CAPA progress.

Education

• The Hyderabad Public School Ramanthapur - HPS (R)

  High School

  2009

• University of Washington

  Master's degree, Mechanical Engineering

  2017 — 2018

• PES University

  Bachelor's degree, Mechanical Engineering

  2012 — 2016