Senior Specialist, Product Quality Assurance (PQA)

Abbott • Lake Forest, CA

22h • $78,000 - $156,000 • Onsite

About The Position

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Their portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Abbott has 115,000 colleagues serving people in more than 160 countries. This position is located in Lake Forest, IL or Dallas, TX, within the Core Lab, Diagnostics Division. The role focuses on empowering smarter medical and economic decision-making to help transform health management. The Senior Specialist, Product Quality Assurance, will conduct post-market 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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• Document monthly Tracking and Trending reports, write customer inquiry responses, collaborate with cross-functional 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.

Benefits

• 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 bachelor’s 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.
• Health and wellness benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees