- Repligen (Waltham, MA)
- …hosting customer/regulatory audits and Certificate of Quality generation at an ISO 9001:2015 certified manufacturing site. We are an innovative life sciences ... & Proteins.ResponsibilitiesThe Director, Quality will be responsible for:Maintaining site compliance to ISO 9001 for all aspects of the QMS including but not limited… more
- Monster (Northfield, IL)
- …ensure devices meet user needs and intended uses. The engineer should be familiar with ISO 14971, ISO 62366, IEC 60601-1-6, AAMI HE75, and general Medical Device ... and Healthcare regulations (21 CFR 820 and ISO 13485).Job Description Working with internal and external resources,...to comply with the latest industry standards and regulations ( ISO 14971, HE75, IEC 62366, IEC 60601, etc.). Lead… more
- Monster (Manhattan, NY)
- …and planning of tabletop exercises o Regulatory deadlines and attestations o ISO 27001 Program including key activities, internal and external audit, and InfoSec ... changes in client-relevant regulatory environments (eg, SEC, NY SHIELD Act, ISO 27001). Identify trends and communicate legislative developments to clients and… more
- Monster (Tolleson, AZ)
- …health and safety (EHS) management systems including the ISO14001 and ISO 45001 programs. Direct and facilitate the development, implementation, maintenance, and ... a manufacturing environment Required Skills: Knowledge of OSHA, EPA, ISO 14001, and ISO 45001 and other relevant regulations and standards. Working knowledge… more
- Merck & Co. (Rahway, NJ)
- …working knowledge of standards relevant to device components and combination products, including ISO 11608, ISO 11040, ISO 80369, as well as ... performance tests related to container closure integrity and dose accuracy, among others.Proven track record of applying analytical skills in product test method design, development, and validation.Working knowledge of analytical test method technology… more
- Monster (Lakewood, NJ)
- …is essential to maintaining the Company's reputation for quality, supporting ISO certification, and driving ongoing improvement, and consistently in the Company's ... manage, and improve the Quality Management System (QMS) in alignment with ISO 9001:2015 standards. Supervise quality control staff and coordinate day-to-day quality… more
- Twist BioScience (South San Francisco, CA)
- …other locations worldwide. This includes maintaining and supporting CGMP and ISO certified production facilities.What You'll be DoingResponsible for the management ... design, and execution, including reconfiguration and expansion.Follow regulatory and ISO 13485 requirements.What You'll Bring to the TeamBachelor's degree or… more
- Monster (Camden, NJ)
- …concerned with the Client Quality Management System in all areas of the ISO 9001:2015/AS9100 QMS. Under general direction from the site Quality leader this position ... records are kept up to date and conform to ISO 9001:2015/AS9100:2016, DCMA, and other relevant standards as required....with, auditing to, and managing systems aligned with AS9100:2016, ISO 9001:2015, ISO 19011 etc. Assess risk… more
- Monster (Leesburg, VA)
- …for developing and maintaining a quality system that exceeds all of ISO 9001:2015 requirements company wide. Responsible for conducting internal audits and managing ... audits as required by certifications. Responsible for establishing and maintaining ISO 17025 certification program for designated product lines. Must be able… more
- Monster (Romeoville, IL)
- …reports, and permits (EPA, OSHA, state, and local). Auditing sites to maintain compliance with ISO 9001, ISO 14001, and ISO 45001 standards. Supporting the ... QHSE Manager in sustaining ISO certifications and driving continuous improvement. Your Profile / Qualifications What We're Looking For Education: Two-year degree in… more
- Monster (Monroe, NC)
- …capability studies, design of experiments, etc. Supports all aspects of the ISO Certified Quality System, including planning, control and improvement, and the ... cover a variety of products/processes which are controlled by detailed ISO procedures and instructions. Within established parameters, the Quality Manager recommends… more
- Merck & Co. (Rahway, NJ)
- …divisional and local site procedures.Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management ... systems.Qualifications:Bachelor's degree in mechanical engineering, Biomedical Engineer, or a related a technical field (eg, Chemical Engineering, Materials Engineering) required; advanced degree (Master's or PhD) preferred.Minimum of 8 years of experience in… more
- Merck & Co. (Rahway, NJ)
- …divisional and local site procedures.Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management ... systems.Qualifications:Bachelor's degree in Mechanical Engineering, Biomedical Engineer, or a related a technical field (eg, Chemical Engineering, Materials Engineering) required; advanced degree (Master's or PhD) preferred.Minimum of 10 years of experience in… more
- Monster (Springfield, IL)
- …biological risks Prepares risk assessments, evaluation plans and reports, in compliance with ISO 10993 and ISO 14971,for submissions to FDA and other regulatory ... risk assessments, identify gaps, and propose solutions. Represent Medline on various ASTM/AAM/ ISO technical committees and contribute to the development of new test… more
- Monster (Dallas, TX)
- …as well as current Good Manufacturing Practices Cleaning and disinfection of the ISO 7 cleanrooms daily, monthly, and quarterly or as needed Cleaning and ... disinfection of the ISO 5 DHC(s) daily, monthly, quarterly, or as needed....quarterly, or as needed. Cleaning and disinfection of the ISO 5 LAFH including daily, monthly, and quarterly or… more
- Monster (Leesburg, VA)
- …in a team environment. Demonstrated knowledge and application of applicable ISO processes. Excellent analytical skills. Strong computer skills, including MS Word, ... Electronic test and quality standards (DO-160, DO-178, DO-254, EN 61000, EN55011, ISO 9001:2015, ISO 17025). **Benefits include Insurance: medical, dental,… more
- Monster (Oxford, OH)
- …job safety analysis and hazard assessment. Coordinate accident investigation and reporting. Facilitate ISO 45001 and ISO 14001. Promote a culture of zero ... educating the overall team on safety, health, and environmental aspects. Knowledge of ISO 14000 & OHSAS standards. Ability and willingness to train large groups of… more
- Monster (Pittsburgh, PA)
- …of Zscaler configurations to ensure compliance with industry standards (eg, NIST, ISO 27001) and internal policies. * Provide technical expertise for Zscaler ... log analysis and monitoring. Knowledge of cybersecurity frameworks (eg, NIST, ISO 27001) and compliance requirements. Flex Skills/Nice to Have: Python Proficiency… more
- Monster (Germantown, WI)
- …responsible for maintaining and improving quality processes that align with ISO standards, customer expectations, and regulatory requirements. The role includes ... and improve the Quality Management System (QMS) in accordance with ISO 9001, internal MGS procedures, customer-specific requirements, and applicable regulatory… more
- Merck & Co. (Rahway, NJ)
- …Autoinjectors, ensuring compliance with industry standards and regulatory requirements (eg, ISO 13485, FDA regulations). Actively seek out, anticipate, and solve ... testing.Regulatory Compliance:Strong knowledge of relevant regulatory requirements such as ISO , USP, FDA guidelines, and other global regulatory standards pertaining… more
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