Product QA Analyst

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 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Job Description:

Analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.

Responsibilities

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.

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.

Education/Experience

Bachelor's degree plus 2-5 years of related work experience with a good understanding of specified functional area, or an equivalent combination of education and work experience.

(Technical/Business Knowledge (Job Skills)) Working knowledge and application of business concepts, procedures and practices. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental

regulations.;

(Cognitive Skills) Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a general knowledge of technical

alternatives and an understanding of their impact on the systems environment.

(Influence/Leadership)

Cultivates a wide range of internal networks and begins to develop an external network of resources to facilitate completion of tasks. May demonstrate basic project management skills by acting as a project lead on small, well defined projects. Provides guidance to less

experienced staff. Influence exerted at peer level and occasionally at first levels of management.;

(Planning/Organization) Plans, organizes, and prioritizes own daily work routine to meet established schedule.;

(Decision Making/Impact) Exercises authority and judgment within defined limits to determine appropriate action. Failure to achieve results or erroneous decisions or recommendations may cause delays and may result in the allocation of additional

resources

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