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 113,000 colleagues serve people in more than 160 countries.
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 109,000 colleagues serve people in more than 160 countries.
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. Our location in Temecula, CA, currently has an opportunity for a Senior Quality Engineer.
Primary Job Function
Identify, analyze, investigate, monitor and document patterns and trends in post marketing surveillance data as part of the CAPA system. Analyze and investigate product complaints from the field as part of post market surveillance requirements. Communicate and educate management, R&D, marketing, sales organization and other departments, as well as external customers about product performance. Ensure that information and insight gained from the investigations and corrective actions is fed back to the R&D and marketing organizations as part of the risk management and design input systems. Develop Post Market Surveillance Plans and provide engineering support for complaint investigation readiness of new products.
Core Job Responsibilities Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Analyzes customer complaints, events and other post marketing surveillance data by examining the data forpatterns and trends and investigating when necessary.;
Investigates customer complaints related to productquality or patient safety.;
Investigates identified trends by starting a formal trend investigation and trend report and working on cross-functional teams.;
Documents trend action by updating the trend report atappropriate levels and by performing a Health Risk Analysis.;
Communicates product performance by formalpresentations to management committees and design teams, supporting published product performance reports and supporting customer requests for performance information either directly or through the sales organization.;
Provides input for process improvement and helps develops tactical approaches to implementteam strategies.;
Develop test plans, procedures, justifications papers and provide engineering support fornew product complaint readiness.
(Supervision Received) Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.;
(Supervision Provided) May provide work direction and guidance to exempt and/or skilled nonexempt levels of employees; may be asked to evaluate performance of and assist in career development planning for subordinates.
Position Accountability / Scope (Influence/Leadership) Establishes and cultivates an extensive network of support to facilitate completion of assignments. Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel. May lead a project team. Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions. May interact with vendors.;
(Planning/Organization) Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule. Establishes priorities of work assignments.;
(Decision Making/Impact) Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
Bachelor's degree plus 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.
Minimum Experience / Training Required
(Technical/Business Knowledge (Job Skills)) Wide application of technical principles, practices, and procedures. Strong understanding of business unit function and cross group dependencies/relationships.
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 diverse scope 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 various technical alternatives and their impact.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
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