- Prysmian (Bridgewater, NJ)
- …for ensuring the plant meets its stated business objectives and maintains the plant's ISO 9001 QMS. The Quality Manager will serve as support for Huston and Taunton ... analysis and problem solving + Metrological knowledge + Proficient in understanding ISO 9001. Awareness of ISO 14001 and ISO 45001. + Knowledge of auditing… more
- Teleflex (Chelmsford, MA)
- …management, and medical device Quality Management Systems per 21 CFR 820, ISO 13485 and 14971. **Principal Responsibilities** * Create, investigate and/or manage ... Excel. * Quality Assurance (21CFR820, ISO13485) and Risk Management ( ISO 14971) experience desired * Experience with Corrective Action.../ Other Requirements** * Quality Assurance (21 CFR 820, ISO 13485) and Risk Management ( ISO 14971)… more
- Carrier (Beverly, MA)
- …Interpret and monitor global regulatory requirements (eg, CE/MDR, FDA, ISO standards, environmental/transport regulations, wireless communications, data security). + ... sensor regulations + Experience with global standards such as: ISO 13485 (Quality management for medical devices); ISO... ISO 13485 (Quality management for medical devices); ISO 14971 (Risk management for medical devices); ISO… more
- L3Harris (Lompoc, CA)
- …pivotal in operating and maintaining the Integrated Processing Facility (IPF), an ISO Class 7 cleanroom environment critical for processing space hardware in ... audits, enforcing gowning procedures and protocols, and ensuring adherence to ISO standards and regulatory compliance. + Participate in the installation,… more
- Xylem (Chaska, MN)
- …+ Create Certificates of Conformance when needed. + Make requested changes to ISO documentation. + Support ISO 9001 audit preparation and other various ... similar role + Ability to read and comprehend blueprints with GD&T + ISO 9001 or equivalent experience preferred + Certifications an advantage including Quality… more
- Cardinal Health (East Rutherford, NJ)
- …balance, PTS, laminar flow hood and fume hood) + Performs environmental and personnel monitoring in ISO 5, ISO 7, and ISO 8 environments + Works in ... ISO 7 cleanroom to make product vials and customer vials for use in drug production + Coordinates daily production run schedule based on customer and pharmacy needs + Demonstrates strong documentation practices, oral communication, and writing skills.… more
- Palo Alto Networks (Santa Clara, CA)
- …management + At least 5 years experience managing third party audits such as SOC2, ISO 27001 ( and/or other ISO extensions), and PCI-DSS + Skilled in ... experience in one or more of these certifications including ISO 27001 (and/or other ISO extensions), SOC2,...these certifications including ISO 27001 (and/or other ISO extensions), SOC2, PCI or other country-specific certifications for… more
- Rochester Institute of Technology (Rochester, NY)
- …projects, contracts, technical support, and client consultations. + Represent IPI at ISO enclosures and image stability standards group meetings including attending ... ISO meetings, responding to and voting on documents and...a project leader when needed to revise and update ISO standards related to preservation materials testing. + Presentation… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …Mastery of MedTech regulations and standards (eg, (eg, 21 CFR 812, 50, 54, 56, ISO 14155, ISO 20916, ISO 13485, ISO 14971, EU MDR/IVDR, China FDA, JGCP, ... ICH E6) At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office… more
- LSI Solutions (Victor, NY)
- …at a medical device company operating within a Quality Management System (QMS) certified to ISO 13485. + Familiar with 21 CFR 820, 21 CFR 803, and ISO ... operating within a Quality Management System (QMS) certified to ISO 13485, said experience relevant to and demonstrating effective...Familiar with 21 CFR 820, 21 CFR 803, and ISO 13485. Also familiar with Canadian, European, Japanese, Australian,… more