Product Surveillance Tech

2 months ago


North Chicago, United States Spectraforce Technologies Full time
Job Title: Product Surveillance Tech

Duration: 6 Months ( Posibility of extension)

Location: North Chicago, IL (60064)

What are the top 3-5 skills, experience or education required for this position:

1. Bachelor's degree and 1-2 year in customer service or clinical setting or equivalent combination of education and experience.

2. Familiarity with Regulation pertaining to devices/510K (i.e. FDA, MHRA, etc.)

3. Flexibility in managing multiple tasks and expectations.

JOB SUMMARY:

Under general direction, the Post market QA PMQA Analyst I will investigate and maintain complaint files, in compliance with regulations established by the FDA and international regulatory bodies and submit safety reports to the FDA and international Competent Authorities.

In addition will process claims for financial reimbursement and replacement products in accordance with client/ Allergan's reimbursement policy. Act as a key resource within the department by mentoring Representatives, monitoring complaints and call queues, and providing ongoing coaching and training. The Post market QA PMQA Analyst is a subject matter expert due to demonstrated excellence in work performance and mastery of the knowledge, tasks, and skill sets. Provides technical and administrative support to internal and external customers.

"The candidate must conduct their work activities in compliance with all client/Allergan internal requirements and with all applicable regulatory requirements, including knowledge of operating in a controlled environment per the requirements of 21 CFR 820, ISO 13485 and ISO 14971. client/Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives."

KEY DUTIES AND RESPONSIBILITIES: DESCRIBE SCOPE:

1. Initiate, investigate, and maintain complaint files following complaint handling regulation 21 CFR 820.198 and internal procedures. Analyze information obtained and make follow up calls to reporters.

* Initiate and set up complaint files. Maintain and update database. Record all complaint activity in both hard copy (when applicable) and computer files. Code complaint information according to Post Market Spreadsheet Report (PSR), Retrieval Program.

* Assess incoming documentation, including clinical forms and medical information, for complaint data and ascertain compliance to product specification and/or intended use as indicated in the product labeling. Evaluate internal and external lab analysis. Coordinate with inter- and intra-departmental customers to ensure complaints and inquiries across product lines are handled appropriately.

* Initiate Further Investigation and any additional follow-up and communication pertinent to the MDR as needed. Track files sent to Quality Assurance for Further Investigation and complete necessary documentation. Evaluate Further Investigation results, summarize findings, and determine and document the conclusion(s).

* Assist Supervisors and Manager in monitoring complaint and claims workflow to ensure compliance and customer service.

* Assist in resolving issues by responding to inquiries and answering technical questions regarding Allergan/ client product line.

Education and Experience:

Bachelor's degree with one to two years previous experience in customer service or clinical setting or equivalent combination of education and experience.

Essential Skills, Experience, and Competencies (includes Licenses, Credentials)?

* Customer service experience

* Familiarity with Regulation pertaining to devices/510K (i.e. FDA, MHRA, etc.)

* Flexibility in managing multiple tasks and expectations.

  • North Chicago, United States US Tech Solutions Full time

    Duration: 6 Months Employment Type:W-2 JOB SUMMARY:Under general direction, the Post Market Quality Assurance (PMQA) Analyst I will investigate and maintain complaint files, in compliance with regulations established by the FDA and international regulatory bodies, and submit safety reports to the FDA and international Competent Authorities.In addition will...

  • Trade Surveillance

    4 weeks ago


    Chicago, United States Larson Maddox Full time

    We are currently partnered with a leading hedge fund looking to add to a Trade Surveillance Compliance Officer to their growing Team.The Compliance Officer will focus on trading surveillance, particularly to detect market manipulation and insider trading, with an emphasis on over-the-counter products such as Foreign Exchange, Precious Metals, Swaps, and...

  • Engineer III

    6 days ago


    North Chicago, United States US Tech Solutions Full time

    Duration: 12 months contract Job Description: The Contractor Engineer Combination Products works under technical supervision on project teams in support of combination products and medical devices. Activities include contributing to product design documentation and conducting laboratory studies of product performance in support of product development,...

  • Engineer III

    4 days ago


    North Chicago, United States US Tech Solutions Full time

    Duration: 12 months contract Job Description: The Contractor Engineer Combination Products works under technical supervision on project teams in support of combination products and medical devices. Activities include contributing to product design documentation and conducting laboratory studies of product performance in support of product development,...

  • Mechanical Engineer

    3 days ago


    North Chicago, Illinois, United States US Tech Solutions Full time

    About the RoleWe are seeking a highly skilled Design Engineer to join our team at US Tech Solutions. As a Design Engineer, you will play a critical role in the development of medical devices and combination products.Key ResponsibilitiesProduct Design and DevelopmentContribute to the design and development of medical devices and combination...


  • Chicago, United States Northern Trust Full time

    About Northern Trust: Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889. Northern Trust is proud to provide innovative financial services and guidance to the world’s most successful individuals, families, and institutions by remaining true to our enduring...


  • Chicago, Illinois, United States Leapfrog Product Development Full time

    About the RoleWe are seeking a highly skilled Senior Industrial Designer to join our team at Leapfrog Product Development. As a key member of our design team, you will play a crucial role in the creation and development of innovative, user-centered products from concept to completion.Key ResponsibilitiesTranslate consumer insights into functional and...


  • North Chicago, United States AbbVie Full time

    Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in...


  • North Chicago, United States AbbVie Full time

    Job DescriptionJob DescriptionCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and...

  • Production Tech

    2 weeks ago


    North East, United States Silgan Containers Full time

    MAJOR RESPONSIBILITIES:Operate Trimmer and auxiliary equipment:Demonstrate ability to meet Quality and production goals with a sense of urgency to keep machines running. Troubleshoot trimmer issues and make necessary adjustments. Quality checks:Trimm Production, Tech, Manufacturing, Trimmer, Robot


  • Chicago, Illinois, United States SGS Société Générale de Surveillance SA Full time

    Position OverviewWe are seeking an Equity Sales Representative to contribute to the Chicago office of SGS Société Générale de Surveillance SA's distinguished Equity Distribution platform. This role presents a unique chance to immerse yourself in the realm of global institutional equity sales.Key Responsibilities:Develop a comprehensive understanding of...


  • Chicago, Illinois, United States SGS Société Générale de Surveillance SA Full time

    Position Overview:As a Summer Analyst in Investment Banking, you will play a vital role in supporting our deal teams throughout the transaction process. Your responsibilities will include:Transaction Support: Assist in the preparation and execution of various financial transactions.Financial Analysis: Develop and maintain comprehensive financial models and...


  • Chicago, United States G-TECH Services Full time $25 - $27

    Job DescriptionJob DescriptionAutomotive Production Supervisor Supervise, evaluate, and empower an hourly team that produces manufactured products, and organize workflow to meet quality and daily productivity requirements• Ensure safety, quality, and productivity objectives are met through coaching standardized work, verifying lines are running safely,...


  • Chicago, Illinois, United States SGS Société Générale de Surveillance SA Full time

    Position OverviewWe are seeking an Equity Sales Representative to become a vital part of SGS Société Générale de Surveillance SA's esteemed Equity Distribution platform. This role offers a remarkable opportunity to gain insight into the realm of global institutional equity sales.Key Responsibilities:As an Equity Sales Representative, you will:Develop a...


  • Chicago, Illinois, United States SGS Société Générale de Surveillance SA Full time

    Position OverviewWe are seeking an Equity Sales Representative to contribute to the Chicago office of SGS Société Générale de Surveillance SA's distinguished Equity Distribution platform. This role presents a unique chance to immerse yourself in the dynamic field of global institutional equity sales.Key Responsibilities:As an Equity Sales Representative,...

  • Design Engineer

    3 days ago


    North Chicago, Illinois, United States US Tech Solutions Full time

    Job SummaryWe are seeking a highly skilled Design Engineer to join our team at US Tech Solutions. As a Design Engineer, you will be responsible for contributing to product design documentation and conducting laboratory studies of product performance in support of product development, manufacturing transfers, and investigations.Key ResponsibilitiesProduct...

  • Engineer III

    4 days ago


    North Chicago, United States US Tech Solutions Full time

    Duration: 12 months contract Job Description: The Contractor Engineer Combination Products works under technical supervision on project teams in support of combination products and medical devices . Activities include....

  • QA Specialist I

    1 month ago


    North Chicago, United States US Tech Solutions Full time

    Duration: 12 Months Employment Type:W-2 Purpose:Perform sampling, inspecting, and physical testing of incoming commodities per appropriate product specification in a laboratory environment.Applies scientific knowledge to daily operations, data management, and problem solving. Understands and follows documentation.Analyzes basic/simple data, evaluates...

  • QA Specialist I

    3 weeks ago


    North Chicago, United States US Tech Solutions Full time

    Duration: 12 Months Employment Type:W-2 Purpose:Perform sampling, inspecting, and physical testing of incoming commodities per appropriate product specification in a laboratory environment.Applies scientific knowledge to daily operations, data management, and problem solving. Understands and follows documentation.Analyzes basic/simple data, evaluates...

  • Project Manager III

    5 days ago


    North Chicago, United States US Tech Solutions Full time

    Duration: 1 year, possibility to extend Employment Type:W-2 Background: The Combination Product Development (CPD) function provides design and development expertise to enable drug delivery systems for pharmaceuticals. This role will support the Human Factors (HF) and Program Management (PM) teams within CPD. The Human Factors (HF) group manages the...