Product Surveillance Analyst II

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 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 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.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with 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 a best place to work for diversity, working mothers, female executives, and scientists.
  
  

The Opportunity

This position works out of our Plymouth MN location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

What You’ll Work On

• Analyze quality standards for components, materials or services.
• Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met.
• Apply quality principles, analyzes quality records, prepares reports and recommends improvements.
• Conduct inspection, verification and validation of components or materials used in development processes.
• Identify and address recurring problems either with the quality of the product or the reliability of testing procedures.
• Document quality issues and performance measures for management review.
• May liaise with external vendors.
• Communicates verbally and in writing both internally and externally regarding information needed specific to new product complaints (e.g. physicians, hospital personnel, sales representatives, international offices), initiates and manages the complaint file
• Evaluates complaints/events accurately and in a timely manner
• Maintains accurate entry of complaints in database, following Good Manufacturing Practices (GMP) for documentation.
• Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities) and sends reports within required timeframes
• Supports complaint database upgrades and conversions by providing input and performing system testing; Ensures accurate department procedures and work instructions are maintained; Support inspections by regulatory agencies (e.g. FDA, TUV) as requested.
  
  

Required Qualifications

• Four-year degree, preferably in the healthcare or science fields; or 2-year degree and relevant experience supporting complaint handling investigations, medical device reporting, or product analysis. Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess the strengths suitable for this position.
• Knowledge of global regulations for medical device reporting and medical terminology is a plus.
• Strong written and oral communication skills are required.
• Candidate must be able to work well independently and on teams in a busy department while managing multiple projects
  
  

Apply Now

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 $60,000.00 – $120,000.00. In specific locations, the pay range may vary from the range posted.