**Quality Assurance Product Support Specialist II**
Location United States - Illinois - Abbott Park Category Quality JOB DESCRIPTION Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
**About Abbott**
The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbotts life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.
Our pioneering technology spans the world of healthcare operations with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.
The position of **Quality Assurance Product Support Specialist II** is within our Infectious Disease Developed Markets business unit located at **Abbott Park, IL**. In this role you will manage and maintain various regulatory compliance programs, as well as providing specific and advanced support as needed to other quality assurance functions and customers. This position is expected to provide problem solving skills and critical thinking for investigation and troubleshooting activities.
**WHAT YOULL DO**
* Manages the site Customer Complaint Investigation Program, including responsibility for deciding which complaints will be investigated, how they will be investigated, coordinating data generating activities, evaluating data and writing investigation summaries/conclusions.
* Maintains effective communication with Technical Service groups (worldwide locations) regarding this sites product complaint investigations. Includes review of complaint cases at earliest stage to assess Technical Service performance.
* Labelling Regulatory Compliance, including reviewing product labeling to assure compliance with product claims and supporting the labelling control process.
* Product Recall / Field Action Activities; coordinate activities as required.
* Post Market Surveillance; responsibility for coordinating and implementing this program. May include generation, maintenance and reporting of key metrics for the site.
* Maintains, administers and distributes technical training materials to outside intake groups as well as internal employees.
* Youll be accountable for meeting our compliance standards including FDA, OSHA and Abbott policies and procedures.
* Conducts training on performance and usage of key products for external or internal employees as well as customers. Includes specific instructions for new product launches. May require interfacing within key groups related to the DHF process.
* Performs bench testing of any products where Abbott Diagnostics Scarborough is the Regulatory Owner.
* Performs site visits as needed to assess kit performance, including specific activities for Amplicon remediation.
* Participates in the Internal Audit program as a lead auditor and for external vendor audits as needed.
* Manage the calibration program as needed
* Manage the Freeze/Thaw stability Program as needed.
* Writes, reviews and approves Standard Operating Procedures, guidance documents, and training materials as needed.
* Identifies events that may be subject to vigilance reporting requirements and communicate to Regulatory for evaluation.
**EDUCATION AND EXPERIENCE YOULL BRING**
**Required**
* Bachelors Degree in Chemistry, Biology, Life Sciences, or related technical field or equivalent combination of education and experience.
* Proficient in the use of Database software; Internet software; Spreadsheet software and Word Processing software.
* Ability to travel approximately 10% of the time
**Preferred**
* 5+ years of experience in Quality Assurance role in the medical device industry
* 2+ years of experience in QA/QC role in animal health industry
**Competencies**
* Working knowledge and experience with FDA cGMPs/QSR, and ISO Quality system requirements.
* Demonstrated understanding of lab practices. Demonstrated ability to manage complex programs, and multiple priorities in a timely manner.
* Demonstrated ability to analyze data and draw appropriate conclusions.
* Strong communication skills.
**WHAT WE OFFER**
At Abbott, you can have a good job that can grow into a great career. We offer:
* **Training and career development**, with onboarding programs for new employees and tuition assistance
* **Financial security** through competitive compensation, incentives and retirement plans
* **Health care and well-being programs** including medical, dental, vision, wellness and occupational health programs
* **Paid time off**
* **401(k)** retirement savings with a generous company match
* **The stability of a company** with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully:
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
**An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.**
We provide reasonable accommodation to qualified individuals with disabilities.
**Job Id** 31011177 **Location** United States - Illinois - Abbott Park **Medical surveillance** Not Applicable **Division** IDDM ARDx Infectious Disease Developed Markets **Travel** Not specified **Additional Location** **Accessibility Statement****Compliance status** We firmly believe that the internet should be available and accessible to anyone and are committed to providing a website that is accessible to the broadest possible audience, regardless of ability.
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