Post Market Surveillance Product Quality Engineer

4 weeks ago


New York, United States Compunnel Full time

Job Description: The Quality Engineer position within THV Quality Engineering, Global Product Surveillance (GPS), is a critical role responsible for leading and performing engineering investigations on globally reported complaints for returned and non-returned devices. The incumbent will apply their knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and companies systems/procedures for device investigation and risk assessments. Key Responsibilities: Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports. Perform hands-on device investigation using visual, dimensional, and test equipment to determine root cause. Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed. Participate in escalation tasks and activities, including Project Risk Assessments (PRA) and Corrective/Preventive action(s) (CAPAs, SCARs), as determined by investigation. Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device related issues. Perform other incidental duties assigned by Leadership, such as assisting in ad hoc complaint analysis or metric review. Education and Experience: Bachelor's Degree or equivalent in Engineering or Scientific field, with 2 years of related work experience required; or Master's Degree or equivalent in Engineering or Scientific field, with 1 year of experience including either industry or industry/education required. Experience in medical devices (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred. Experience in complaint investigations, root cause analysis, and associated risk assessments preferred. Additional Skills: Strong documentation, communication, and interpersonal relationship skills, including negotiating and relationship management skills. Basic understanding of statistical techniques. Previous experience working with lab/industrial equipment required. Solid problem-solving, organizational, analytical, and critical thinking skills. Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering. Knowledge of and adherence to Quality systems. Strict attention to detail. Ability to interact professionally with all organizational levels. Ability to manage competing priorities in a fast-paced environment. Must be able to work in a team environment, including the ability to manage project stakeholders. Ability to build productive internal/external working relationships



  • New York, United States a Medical Device company near Monroe, CT Full time

    Post Market Surveillance Associate RESPONSIBILITIES Managing day-to-day operations and collaborating across departments. Communicating information through the department email inbox. Executing field action tasks, including translations, mailings, and tracking. Collaborating with cross-functional teams to collect data and complete documents. Ensuring ongoing...


  • New York, United States a Medical Device company near Monroe, CT Full time

    Post Market Surveillance Associate RESPONSIBILITIES Managing day-to-day operations and collaborating across departments. Communicating information through the department email inbox. Executing field action tasks, including translations, mailings, and tracking. Collaborating with cross-functional teams to collect data and complete documents. Ensuring ongoing...


  • New York, New York, United States Kalshi Full time

    What we're up toKalshi has launched the first regulated financial exchange that allows people to trade on the anticipated outcome of events. We're now looking for the right people to help us continue to grow and scale.Our vision is to allow people to capitalize on their opinions and hedge risks that relate to their everyday lives, from "Will CPI rise more...


  • New York, New York, United States Bank of America Full time

    Job Description:At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. Responsible Growth is how we run our company and how we deliver for our clients, teammates, communities and shareholders every day.One of the keys to driving Responsible Growth is being a great place to work for our...

  • Trade Surveillance

    4 weeks ago


    New York, United States Lime Trading Full time

    Lime Trading Corp., a financial services company for retail and institutional traders, is ready for the next stage of our growth. Although we are an established company with dedicated investors and long-term clients, Lime Trading is in the midst of an exciting period of expansion. We are thrilled for our rapidly increasing reach in this industry, and we are...

  • Surveillance Analyst

    1 month ago


    New York, United States North Bridge Staffing Group Full time

    Position Title: E-Communications Surveillance AnalystDivision: Legal & ComplianceAbout the Role:The Legal & Compliance Department at our client's firm is dedicated to upholding ethical standards, safeguarding the company's reputation, and fostering a compliance-driven culture.As an Analyst, you will be part of their electronic surveillance team located in...

  • Surveillance Analyst

    2 months ago


    New York, United States North Bridge Staffing Group Full time

    Position Title: E-Communications Surveillance AnalystDivision: Legal & ComplianceAbout the Role:The Legal & Compliance Department at our client's firm is dedicated to upholding ethical standards, safeguarding the company's reputation, and fostering a compliance-driven culture.As an Analyst, you will be part of their electronic surveillance team located in...


  • New York, United States Oppenheimer & Co. Inc. Full time

    **Who We Are**: Oppenheimer & Co. Inc. (“Oppenheimer”) is a leading middle-market investment bank and full service broker-dealer. With roots tracing back to 1881, the Company is engaged in a broad range of activities in the financial services industry, including retail securities brokerage, institutional sales and trading, investment banking (both...

  • Quality Engineer

    2 weeks ago


    New York, United States TalentBurst Full time

    Position: Quality Engineer I (Complaint Investigations), Req#: 6086-1 Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1 Both are short-term (3 months only with no possibility of extension/conversion) contract jobs. Position: Quality Engineer I/II (Complaint Investigations) Location: Irvine, CA (100% onsite) Duration: 3 Months Contract...


  • New York, United States Bank of America Full time

    At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. Responsible Growth is how we run our company and how we deliver for our clients, teammates, communities and shareholders every day. One of the keys to driving Responsible Growth is being a great place to work for our teammates...


  • New York, United States Millennium Management Full time

    Compliance Associate - OTC Surveillance The Compliance Department at Millennium serves to adopt, implement, and carry out a compliance program, including policies and procedures, processes, systems, controls, surveillance, testing and reporting, which is designed to prevent or detect violations of applicable laws, rules and regulatory requirements and Firm...


  • New York, New York, United States TEKsystems Full time

    Key Responsibilities:Work the broader teams such as reporting and Global technology to capture necessary data and automate periodic reports for various surveillance monitoring program and utilize various tools and statistical analysis to make the surveillance program more effective and efficient.The successful candidate will also be reviewing the results of...


  • New York, United States Northbound Search Full time

    Job Description: Trade Surveillance Analyst will be responsible for actively following regulatory trends and responsible of taking appropriate action updating and designing surveillance patterns to ensure the firm has inclusive surveillance coverage. The Compliance personnel will also contribution in developing multi-data format alerts and advanced market...


  • New York, United States Hispanic Technology Executive Council Full time

    This job is responsible for summarizing and organizing GM Communications Review Group (CRG) activity and findings into digestible reports for senior management. Other responsibilities will include learning the technological landscape for voice surveillance and building out the voice communications surveillance program for Global Markets. The candidate will...


  • New York, United States Northbound Search Full time

    Job DescriptionJob DescriptionJob Description:Trade Surveillance Analyst will be responsible for actively following regulatory trends and responsible of taking appropriate action updating and designing surveillance patterns to ensure the firm has inclusive surveillance coverage. The Compliance personnel will also contribution in developing multi-data format...


  • New York, New York, United States Dupont Full time

    Chez DuPont, nous travaillons sur des choses qui comptent ; qu'il s'agisse de fournir de l'eau potable à plus d'un milliard de personnes sur la planète, de produire des matériaux essentiels aux appareils technologiques de tous les jours, tant pour des smartphones que pour des véhicules électriques, ou encore de protéger les travailleurs du monde entier...


  • New York, New York, United States Paperless Post Full time

    Paperless Post seeks an exceptional React-Native Engineer to join our mobile team. In this role, you will work closely with our Product and Mobile team to help us shape, design, and build the mobile Paperless Post experience for our customers across various mobile devices. This role is a great fit for an experienced Mobile developer who is looking to work...


  • New York, New York, United States Paperless Post Full time

    Paperless Post is seeking a Software Engineer that specializes in the frontend to help develop our JavaScript application with more than five million unique visitors per month. In this role, you'll work within a dedicated and fully staffed feature team to build and maintain user-facing features and libraries that are essential for cross-functional...

  • Project Engineer

    1 week ago


    New York, United States Engineer Rec Full time

    Our client are seeking Project Engineers for multiple projects along the East Coast, USA. Are you a Project Engineer currently looking for a new challenge and experienced in supporting offshore wind projects? If so please read on. The Project Engineer has the skills and experience to take a leading role related to land and underground installation of high...


  • New York, New York, United States Dupont Full time

    En DuPont, trabajamos en cosas que importan, ya sea en proporcionar agua limpia a más de mil millones de personas en el planeta, producir materiales esenciales en los dispositivos tecnológicos cotidianos (desde smartphones hasta vehículos eléctricos) o proteger a los trabajadores de todo el mundo. Si deseas ser parte de una empresa multindustrial líder...