- Cardinal Health (Deland, FL)
- …lifecycle - from design control and supplier qualification to manufacturing and post- market surveillance . + Collaborate with engineering, production, and supply ... chain teams to ensure product quality and process compliance. + Train and mentor staff on quality procedures and regulatory requirements. + Lead root cause analysis and problem-solving initiatives for quality issues. + Prepare and present quality metrics and… more
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …track record in Sustaining Engineering, support of commercialized products and Post Market Surveillance . + Strong working knowledge of statistics, sampling ... strategies, and design of experiments, including statisticalsoftware tools such as Minitab. + Strong working knowledge of Risk Management practices, Corrective and Preventative Actions, andregulatory requirements such as FDA QSR's, ISO13485, ISO 14971, ISO… more
- Philips (Plymouth, MN)
- …Management is effective utilizing feedback from validation, field service, post market surveillance , manufacturing indicators, CAPAs, HHAs, and updating risk ... documents, component qualification, statistical analysis of data, design verification and process validation planning as well as quality system compliance. + Provides critical quality review of design requirement rationales, test methods, training requirements… more
- Abbott (Alameda, CA)
- …role in driving digital transformation and operational excellence within Abbott's Post- Market Surveillance (PMS) and complaint handling functions. This role ... partners with cross-functional teams to design and implement scalable automation solutions that enhance traceability, streamline product return workflows, and ensure compliance with global regulatory standards. By aligning business needs with technical… more
- Corewell Health (Grand Rapids, MI)
- …and resource for researching industry practices, sharing best practice and market surveillance information to internal and external customers. Qualifications ... Required + Bachelor's Degree + 5 years of relevant experience in health plan, managed care or healthcare delivery, administration or clinical practice management. Preferred + Knowledge of Health and Population Technology and Provider reporting. + Knowledge of… more
- Philips (San Diego, CA)
- …Management is effective utilizing feedback from validation, field service, post market surveillance , manufacturing indicators, CAPAs, HHAs, etc. **You're the ... right fit if:** + You have a minimum of 8+ years' experience in FDA regulated, IEC 62304 medical device software environments (SiMD/SaMD), with a focus on Software Design Assurance/Control, detailed knowledge of Risk Management (ISO 14971/ AAMI TIR45) and… more
- Abbott (Plano, TX)
- …Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post- market Surveillance Group, Clinical Affairs, Risk Management, Program ... Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers). + Review, edit, and write portions, as needed, of Clinical Evaluation Reports and associated documents. + Participate in and/or lead the development of regulatory… more
- Stryker (Orlando, FL)
- …bio medical and nursing staff Interacts with customers with regard to post market surveillance activities. + Responsible for staying current with all ... ComplianceWire training with none past due. + Other duties as assigned by manager. + Has the independence and authority to perform required tasks to ensure all provisions of the quality system are met. **PHYSICAL REQUIREMENTS** + Heavy work: Exerting up to 50… more
- ZOLL Medical Corporation (Pawtucket, RI)
- …compliance with ISO 14971 * Develop and implement quality plans* Ensures post market surveillance reviews are conducted and reports documented according to ... schedule* Participate in CAPA efforts, and apply systematic problem-solving methodologies identifying, prioritizing, communicating, and driving resolution of quality issues.* Provide key quality trending information and data for Management Review and monthly… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …IMDRF dictionary terms and proficiency in adverse event coding and reportingPost market surveillance , escalations, and mandatory safety reporting requirements. + ... Endoscopic diagnostic and therapeutic procedures in the following therapeutic areas: Gastroenterology, Pulmonary, ENT, General Surgery, Neurological Surgery, Orthopaedic Surgery, Urology, Obstetrics/Genecology, Infectious Disease, Infection Prevention and… more