verification and validation activities comply with FDA 21 CFR Part 820, ISO 13485, and IEC 62304. Collaborates with Systems... Comprehensive understanding of FDA QSR, ISO 13485, and IEC 62304 Strong experience with test protocol development, execution...
or exceed the standards set by ISO/IEC 17025, government regulatory (cGMP, GLP), and company requirements relevant to assigned...
compliance with ISO/IEC, FDA, USDA, and other relevant regulatory standards. Oversee internal audits, proficiency testing...
to produce to the highest standards, including ranges produced under ISO/IEC 17025 and accredited to ISO 17034. Our wide range...
Strong knowledge of control systems design principles, codes, and standards to include direct experience with NIST SP 800 and/or IEC...
or exceed ISO/IEC, government regulatory (cGMP, GLP), and company requirements relevant to assigned duties. Additionally, the... to responsibilities such as Quality Manual, SOPs, and Methods. Adhere to quality measures to meet or exceed the standards set by ISO/IEC...
on plastics (ISO, ASTM, IEC, DIN, etc.). Must be energetic, self-motivated, flexible/adaptable and with good time management...
governance frameworks aligned to standards such as NIST AI RMF, ISO/IEC 42001, and EU AI Act guidance Translate technical... and AI Security frameworks (e.g., GDPR, NIST AI RMF, ISO/IEC 27001, ISO/IEC 42001, OWASP Top 10 for LLMs, MITRE ATLAS...
documentation (e.g., 510(k), IEC standards). Provide technical leadership and mentorship to the team, fostering a culture..., verification methodologies, and design control processes. Desired Characteristics Familiarity with IEC standards (e.g., IEC...
, etc.) Familiarity with industry standards and compliance (e.g. ISO, IEC, FCC) Familiarity with signal integrity, power integrity...