DirecciónAbbott 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 114,000 colleagues serve people in more than 160 countries.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- An excellent retirement savings plan with a high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
We have an exciting opportunity for a Senior Specialist - Product Quality Assurance within our Abbott Point of Care business division in Princeton, NJ.
Abbott Point of Care (APOC) is a global leader in providing critical medical diagnostic and data management products for rapid blood analysis that are intuitive, reliable, and cost-effective. Our i-STAT System is an advanced, portable diagnostic tool that provides real-time, lab-quality results within minutes to accelerate patient-care decision-making. The i-STAT System has the industry’s most comprehensive menu of tests in a single, with-patient platform, including tests for blood gases, electrolytes, chemistries, coagulation, hematology, glucose, and cardiac markers. By delivering lab-quality results in minutes, our i-STAT System fosters a collaborative, patient-centered environment while driving improved operational performance.
The position includes management of personnel and activities within the quality operations and manufacturing environment. Completes professional-level engineering and management assignments related to specific fields and disciplines. Leads and participates in projects involving design, fabrication, validation, calibration, and testing of complex instrument subassemblies, systems, or processes.
What You’ll Work On
- Responsibility for implementing and maintaining the effectiveness of the quality system
- Responsible for completing and maintaining documentation promptly and by business standards.
- Review, approve, and close level 2 and level 3 complaint investigation reports to ensure compliance with SOP (standard operating procedures).
- Independently execute assigned tasks by applying standard scientific and GMP theories, concepts, and techniques.
- Conduct a thorough investigation to determine the root cause of the issues (complaint). Document the investigation outcome clearly and concisely and comply with guiding procedures.
- Support Product Quality improvement initiatives
- Provide ongoing support and training for users of Rocketware
- Identifying and evaluating unique ways to improve the organization (cost reductions, uses of resources, policies/procedures, products); generating new ideas, approaches, or techniques
- Uses tracking and trending techniques on the product complaint system. Responsible for monitoring the field quality of Abbott Point of Care products through Technical Support contact, complaint trending, risk evaluations, and corrective and preventative action activity.
- Analyzes quality reports generated by the QA specialist detects and specifies the source of trends and determines the appropriate course of action to resolve identified issues.
- Support multiple investigations, risk evaluations, customer communications, and field actions. Review the output of the database using standard reports to determine the aging cycle of incidents and document discussions and meeting outputs on specific incidents.
- Working knowledge of Federal Regulations (not limited to 21 CFR 806, 21 CFR 820, and Medical Device Reporting Guidelines) and understanding the consequences of product issues on product performance, customer acceptance, customer risk, and compliance.
- Medical Device Report filings and maintenance of database for support of internal and external monthly reports. Implements and maintains the effectiveness of the quality system.
- Uses authority to remove barriers that block goal attainment; influences others to support the identified course of action; takes personal responsibility to resolve issues.
Required Qualifications
- Bachelor’s degree in Life Sciences, Technology, Engineering, or Regulatory Affairs is preferred.
- Minimum 5 years of experience working with Relevant experience, such as Quality, Compliance, and Engineering, within a regulated environment, such as medical device, diagnostics, or pharmaceutical industries.
- Knowledge of regulations and standards affecting IVDs and Biologics
- Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical devices. Previous experience with regulatory body. Advanced knowledge of ISO 9001, EN46001 standards, and applicable US Code of Federal Regulations for Devices, Drugs, and Biologicals.
- Knowledge of quality management techniques and the application and principles of quality engineering. Strong knowledge and application of concepts, practices, and procedures. Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors. Understanding of statistics.
Preferred Qualifications
- Combination of experience with Quality Assurance, Quality Control, or Regulatory Affairs.
- Previous experience with the regulatory interface and prior audit experience are required.
- Working knowledge of ISO/EU standards and FDA Quality System Regulations.
- History of completing successful projects and driving positive compliance outcomes.
- Ability to work in a dynamic and fast-paced environment.
- Must be a strong communicator with peers, team members, and management.
- Familiarity with In vitro Diagnostic or Hematology products is a plus.
- Previous experience with quality system engineering is a plus.
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.
