, etc. · Strong understanding of regulatory compliance requirements (e.g., GDPR, HIPAA, PCI DSS, SOX) and security frameworks (e.g., NIST, ISO 27001...
, ISO 13485, and Medical Device and IVD requirements through the review of NC records at critical phases. -Provide guidance... -Strong analytical and decision making skills -Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO...
Spearhead ISO certification efforts to meet planned deadlines and coordinate activities and procedures necessary to achieve...
. Understands GMP, QSR, ISO and RMS Quality regulations and ensures operations are performed according to those requirements...
, ISO-certified manufacturer of consumer and industrial products located in Southwest Minnesota. They were organized in 1990...
with quality systems such as AS9100, ISO 9001, AS13100 or equivalent · Strong analytical and problem-solving skills...
standards such as GDPR, HIPAA, ISO 27001, etc. Excellent problem-solving skills and the ability to work in a fast-paced...
is a plus. · Familiarity with quality systems such as AS9100, ISO 9001, AS13100 or equivalent · Strong analytical and problem-solving skills...
compliance with QSR, ISO, and company management rules and regulations. Your role includes reviewing processes, supporting audits..., and more. Hard Skills 2+ years of experience in a regulated environment (ideally ISO certified company) Technical proficiency...
Cybersecurity development process per ISO 21434 and OEM specific strategy. Review feature/system Cybersecurity requirements... product per ISO 21434 and UNECE WP.29 and collect required test evidence to build software security case. Support TARA...