- Abbott (Scarborough, ME)
- …for treatment and management of diseases and other conditions. The Quality Specialist - Post Market Surveillance is part of the Quality Compliance group, ... position analyzes quality system and business data to generate Management Review and Post Market Surveillance reports and/or presentations. This will include… more
- Danaher Corporation (Westborough, MA)
- …pharmaceutical) preferred + At least 3 years relevant experience dealing with post market surveillance activities (complaint triage, investigations, CAPA, ... to develop the next generation of life-changing therapeutics. The Senior Quality Assurance Product Surveillance Lead for...with cGMP and/or ISO 13485 including documentation, audit, and post market surveillance preferred +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …needed to support both local and global targets and objectives. + Work with the Post - Market Surveillance department to establish tools and methods needed to ... Senior Global MDR Submission is responsible for managing Market Quality- COE MDR team for the regulatory assessment...processing and submission of potential adverse events. The Manager, Sr . Global MDR Submission works closely with the Global… more
- Zimmer Biomet (Warsaw, IN)
- …and post - market surveillance + Trains and supports Zimmer Biomet Post Market Surveillance and Quality team with product investigations + May ... location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment… more
- Philips (San Diego, CA)
- …MDR (updating Technical Files), 510(k) Worldwide product registrations, clinical evaluations. Post market surveillance . Additionally, responsible for ... The Senior RA Specialist will play a critical role...Files), Worldwide product registrations, Design Dossiers, PMA, clinical evaluations, Post Market Surveillance and reviewing… more
- Terumo Medical Corporation (Elkton, MD)
- …to monitor product/process compliance to the most up-to-date requirements. + Collaborate with Post - Market Surveillance team to establish a robust process for ... Sr . Quality Compliance Engineer Date: Apr 16, 2024 Req ID:...overseeing the management of all post - market sustaining activities required to maintain… more
- PDS Tech Inc (Redmond, WA)
- …and ISO 14971 (Risk Management for Medical Devices). * Experience with the Post - Market Surveillance Analyst to monitor, analyze, and trend complaints. ... **PDS Tech Commercial, Inc. is looking for a Sr . Quality Compliance Engineer for our medical device...BS and 5+ yrs. Experience medical device environment As Sr . Quality Compliance Engineer, you will be responsible for… more
- Zimmer Biomet (Jacksonville, FL)
- …and post - market surveillance + Trains and supports Zimmer Biomet Post Market Surveillance and Quality team with product investigations + May ... location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …standards throughout the product lifecycle, including design, development, testing, and post - market surveillance . + Support regulatory submissions and ... should have the ability to coach, mentor, as well as, work closely with senior management to advance agility at the enterprise level. We would like someone who… more
- Fresenius Medical Center (Lawrence, MA)
- …for the implementation of appropriate cybersecurity measures . Evaluation of events ( post - market surveillance ) within the scope of complaints/incidents and ... vulnerability management coordination of product related cybersecurity activities . Involvement in the definition of policies, SOPs and guidelines for cybersecurity and data privacy **Experience** . 2+ years of relevant experience in medical device… more
- GRAIL (Menlo Park, CA)
- …and safety risk management for all GRAIL products during the product development and post - market surveillance phases. This leadership role will be within the ... Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com . The Sr . Director, Medical Safety will lead the development and implementation of a… more
- Academy Sports + Outdoors (Katy, TX)
- …for resolution. + Maintains database of relevant product incident information; analyzes post -performance/ market surveillance data to determine trends in ... safety and quality issues. + Leads stakeholders, including merchant team, stores, and distribution centers through product compliance investigations, actions, recalls, and other related matters. + Monitors regulatory compliance developments/trends and assesses… more
- ManpowerGroup (South San Francisco, CA)
- …and trending activities, such as data analysis, internal/external audits, CAPA related activities, post market surveillance + Work with software partners to ... ** Senior Manager, Medical Device Technology, Complaint Handling** Our...803. + Demonstrated experience with leading teams responsible for post market complaint investigations for medical devices… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Device preferred). + Strong prior experience in Quality Assurance initiatives including post market surveillance , complaints management, quality KPls, Design ... our core values by staying **True to Life.** **Job Description** The Sr . Manager, Business Development Quality Assurance will support Quality Assurance M&A… more
- Cook Medical (Bloomington, IN)
- …internal and external Audit programs, NC/CAPA processes, Document Management, Management Review, Post Market Surveillance , and Quality Systems Projects. - ... Overview The Senior Manager, Quality Assurance serves on a cross...including premarket/ product development, supplier management, manufacturing, sterilization, and post - market .- Working with subject matter experts, process… more
- Abbott (Menlo Park, CA)
- …the quality system. They collaborate with clinical, design engineering, regulatory, labeling, and post market surveillance functions to ensure that risk is ... for the treatment of structural heart disease. As the Senior Risk Management Engineer, you'll have the chance to...deliverables to ensure continued acceptability of product based on post market feedback + Maintain SOPs, Work… more
- Hologic (San Diego, CA)
- …of nonconforming products, CAPAs, deviations, complaints management, complaint investigations, post - market surveillance , audits, quality system, document ... Senior Director, Quality San Diego, CA, United States...Quality Assurance/Regulatory Compliance management for the design, production, and on- market support of medical or IVD products * Proven… more
- Teleflex (Chelmsford, MA)
- …the Sr . Quality Engineer will support the Operations, Engineering, R&D, and Post Market Surveillance team activities to ensure that product quality ... Senior Quality Engineer **Date:** May 4, 2024 **Location:**...make a difference in patients' lives. **Position Summary** The Sr . Quality Engineer will be responsible for cross-functional quality… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …including product containment arise. + Trend, analyze, and report on quality data (eg, post market surveillance , operations metrics) to improve product and ... grow and become your best self. Become a **maker of possible** with us. The Sr . Quality Engineer will serve as the Core Team quality lead within a cross-functional… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …Evaluation Report for products under their respective platforms and ensures MA aspects of Post Market Surveillance + Drives innovation under their respective ... toxicology to clinical, and human factors, as well as post marketing follow up. The Platform Lead develops a...ensures these plans are aligned with the business and market access needs + Engages with Subject Matter Experts,… more