of Hologic's Quality Management System per ISO, FDA and other regulatory agencies Skills Demonstrated strong emotional... operations, and data entry. Working knowledge of safety regulations, federal regulations and other regulations, e.g. QSR's, ISO...
including, but not limited to, ISO 13585 & IEC 60601 Education and Experience Typically requires a minimum of 10 years...
requirements (e.g., US Quality System Regulations (QSRs), EU in vitro Diagnostics Regulations (IVDR), ISO and other regulations...
through validation and manufacturing. Understanding of regulatory requirements such as FDA cGMP, ISO, CE. Develop mechanical...
of ASML San Diego Factory, Safety, Quality, and ISO 9000/14000/27000 policies and procedures. Provide coaching, mentoring...
, such as PCI, SOC 2, NIST, PCI DSS, HIPAA/HITRUST, and ISO 27001. Identify potential security risks and collaborate with technical..., PCI DSS, HIPAA, ISO 27001). Experience in project management software Experience with Asana or Mavenlink/Kantata...
) – technical writing a plus Working knowledge of Quality Systems Regulations (QSR), Good Manufacturing Practices (GMP) and ISO...
Manufacturing Practices (GMP) and ISO 13485 standards Knowledge of the following scientific related principles, theories...
. Generally knowledgeable and/or supports Lean Management (COS) and regulatory (e.g. ISO, FAA, ITAR, etc.) initiatives...
standards, and ISO standards. Assists in the preparation of documentation for regulatory submissions. Ensures compliance... Kotlin and Swift. Knowledge of regulatory requirements, including FDA, IEC, and ISO standards. Familiarity with FDA...
security clearance. PREFERRED SKILLS Quality Management System (QMS) experience that is compatible with ISO 9001:2008...
(QMS) experience that is compatible with ISO 9001:2008 and 2015. REMARKS Must be able to communicate effectively in...
(QMS) experience that is compatible with ISO 9001:2008 and 2015. REMARKS Must be able to communicate effectively in...
to meeting 21 CFR 820 and ISO 13485, MDSAP, IVDR and other related requirements as appropriate Experience/Education...
and supervises staff to ensure compliance with applicable Inova SOPs, ISO, FDA and other Quality System Regulations...
experience in implementing compliance frameworks such as COSO, COBIT, ISO, PCAOB, NIST, and other IT auditing standards. Working...
Familiar with Medical Device Manufacturing and Design Controls for the development of medical devices such as 21CFR820, ISO... 13485, and ISO 14971 Prior experience managing software in FDA regulated environments Preferred Certifications: SAFe...
, preferably in a life science industry Experience with ISO 9001, ISO 13485, 21CFR820, 21CFR 211, or other regulated industry...
). Strong knowledge of quality standards and methodologies (e.g., Six Sigma, Lean, ISO). Excellent analytical and problem-solving skills...
Qualifications: Experience with ISO 26262 and Functional Safety processes C/C++ programming skills and a good understanding...