Senior Specialist, Product Quality Assurance (PQA)

Senior Specialist Product Quality Assurance

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. Youll 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 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 bachelors degree.

• A company recognized as a great place to work in dozens of countries worldwide 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
This position works out of our Lake Forest IL or Dallas TX location in the Core Lab Diagnostics Division. Were empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day more than 10 million tests are run on Abbotts diagnostics instruments providing lab results for millions of people.

The Senior Specialist Product Quality Assurance will conduct postmarket surveillance activities in compliance with applicable regulatory requirements (e.g. FDA 21 CFR 803 and 806 ISO 13485) including ongoing product monitoring management of internal and external customer communications and execution of risk management activities to support continued product safety and regulatory compliance.

What Youll Work On

• Document monthly Tracking and Trending reports write customer inquiry responses collaborate with crossfunctional teams to develop customer communications complete risk assessments/evaluations and execute field action activities.

• Review complaint communications and assess for regulatory compliance reportability and potential impact to patient safety and business operations.

• Apply clinical knowledge as related to product application to evaluate identified complaints.

• Investigate complaints by gathering sufficient data from clinical staff field representatives internal employees and laboratory analysis.

• Establish regulatory reportability decisions using event investigation and regulatory decision models.

• Participate in development and modification of these decision models with changes in product advances/ therapies to uphold consistent compliance with government mandated regulations.

• Write Medical Device Reports (MDRs) MedWatch Vigilance and other regulatory reports ensuring timely transmission to the appropriate regulatory authorities.

• Apply codes to events to facilitate product performance records.

• Review coding and investigations with engineering laboratory and other internal staff.

• Compose written communications detailing the clinical observation investigation and/or product analysis and corrective actions as applicable to physician and other end use customers.

• Communications include determination/eligibility for warranty credit or unreimbursed medical payments.

• Write and communicate position papers pertaining to clinical perspective for regulatory reporting performing literature research consulting with outside clinical resources to ensure pertinent information is properly disseminated.

Required Qualifications

• Bachelors in related field or an equivalent combination of education and work experience.

• Minimum 6 years related work experience with a strong understanding of specified functional areas.

Preferred Qualifications

• Masters Degree preferred

• Solid understanding and application of business concepts procedures and practices.

• Will perform this job in a quality system environment.

• Works on problems of diverse scopes where analysis of data requires evaluation of identifiable factors.

• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

• Has a sound knowledge of a variety of alternatives and their impact on their business unit.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives: 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.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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Senior IC