- ThermoFisher Scientific (Middletown, VA)
- …Middletown, VA Specialty Diagnostics Group (SDG) **How will you make an impact?** The Medical Device Complaint Handling Specialist III is responsible ... data, and conducting root cause analysis. + Ensure customer complaint investigations are complete, accurate and closed in a...of ISO 13485 and GMP regulations which govern a medical device and diagnostics manufacturing. + Strong… more
- J&J Family of Companies (Santa Clara, CA)
- …or a Bachelor's degree with 2+ years of related quality experience. + Experience with Medical Device Complaint handling , Post Market Surveillance and ... Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated… more
- Astrix Technology (Irvine, CA)
- …+ Knowledge of FDA regulations (21 CFR 820/803), ISO 13485 + Experience with medical device complaint handling and regulatory reporting (MDR, ... work for a global leader dedicated to helping people see brilliantly. The largest device company in the world - with complementary businesses in Surgical and Vision… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …on the medical device industry with attention to complaint handling and adverse event reporting and/or post-market surveillance organization strongly ... (https://www.olympusamerica.com/careers) . **Job Description** Responsible for the review of medical device global complaints and coordinate the resolution… more
- Caldera Medical (Westlake Village, CA)
- …accordance with internal SOPs and regulatory requirements. * Ensure timely and accurate complaint evaluations, including medical device reporting (MDR) or ... Quality team. This position is responsible for overseeing product complaint handling , trending, and reporting while also...CAPA. * Bachelor's degree preferred. * Experience working within medical device industry and familiarity with 21… more
- Abbott (Alameda, CA)
- …on customer-reported software application issues to ensure the reliability and safety of medical device software products. Perform thorough testing of mobile and ... support for fellow peers and other areas of the Complaint Handling Group to meet their objectives,...Qualifications** + Experience in testing mobile/web applications (ideally in medical device industry). + Experience in writing,… more
- Abbott (Alameda, CA)
- …and operational excellence within Abbott's Post-Market Surveillance (PMS) and complaint handling functions. This role partners with cross-functional ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- US Tech Solutions (North Chicago, IL)
- …**KEY DUTIES AND RESPONSIBILITIES: DESCRIBE SCOPE:** + Initiate, investigate, and maintain complaint files following complaint handling regulation 21 CFR ... according to procedures. + Assess incoming documentation, including clinical forms and medical information, for complaint data and ascertain compliance to… more
- DEKA Research & Development (Manchester, NH)
- …and 3+ year(s) relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis; OR ... relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis. + Knowledge of… more
- DEKA Research & Development (Manchester, NH)
- …and 2+ year(s) relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis. + ... for reviewing complaints related to potential medical device issues. + Perform product complaint evaluations...in audits and CAPA investigations as they relate to complaint handling . + Work with the forensic… more
- Jabil (West Chester, PA)
- …new product introductions and process transfers. + Participate in complaint investigations, nonconformances, and CAPA activities. + Collaborate cross-functionally in ... in audits or regulatory inspections. + Working knowledge of complaints handling , document control systems, and inventory management tools. + Certification in… more
- LSI Solutions (Victor, NY)
- …supporting various activities on the Regulatory Team, including administration of LSI's complaint handling system, and assisting with the procurement of domestic ... to gather regulatory intelligence regarding updates to US and international medical device regulations, and supporting Rest-of-World (ROW) regulatory approvals,… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …other departments/business units for complaint investigations + Evaluate complaints for Medical Device Reporting (MDR) + Prepare and submit MDR reports to ... + Bachelor's Degree in related field, 2-5 years experience complaint handling Required andmedical device ...operate general office machinery + Experience working in a medical device (cardiovascular, endovascular, or other critical… more
- Philips (Colorado Springs, CO)
- …Image Guided Therapy Devices (IGTD) quality organization by ensuring compliance of complaint handling returned device analysis processes and assessment ... device /product environments, with proven experience in Quality Planning, Complaint Handling , returns, investigations, Corrections & Removals, Recalls, QMS… more
- GN Hearing (Shakopee, MN)
- …+ Participate in meetings for NA Product Quality including VOC and XMN complaint handling meetings as needed. + Internally Outsource Process review. **Skills ... field and/or equivalent experience (Required). **Experience:** + 5+ years' experience in complaint handling systems, customer solutions, and product quality in a… more
- Cordis (Miami Lakes, FL)
- …devices is preferred + Regulatory Affairs/ Quality Assurance and/or complaint handling experience in the Pharmaceutical or Medical Device industry ... representative._ **ESSENTIAL DUTIES AND RESPONSIBILITIES:** + Provide guidance to Complaint Handling Analysts regarding investigation of product related… more
- BD (Becton, Dickinson and Company) (Columbus, OH)
- …and service department procedures and policies, including customer complaint handling and Medical Device Reporting. **Qualifications Required:** + ... Description** We are **the makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the world of health (TM) is our… more
- Abbott (Alameda, CA)
- …in the Medical Events Group (MEG). Supervision includes answering routine complaint handling questions from individuals in MEG, training, and monitoring ... complaint cases to ensure timely review, proper documentation, and...Medical Events Group (MEG) is compliant with global medical device reporting regulations. This position will… more
- Abbott (Maple Grove, MN)
- …for diversity, working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that are faster, more ... help people with chronic pain or movement disorders, our medical device technologies are designed to help...definition, statistical analysis and analytical techniques. + Experience in complaint handling , operation or service of diagnostic… more
- Medtronic (Minneapolis, MN)
- …Development (NPD) Systems Engineering, quality assurance, and regulatory compliance within the medical device industry. Ensure the development and maintenance of ... Device History Records) and product performance data. Perform Complaint analysis, complaint trending, predictive for newly...Control Charts, & ANOVA; CAPA; and Combination [pharmaceutical and medical device ] Products, (FDA 21 CFR Part… more