Sr. Quality Engineer

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:

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.

1.Analyzes customer complaints, events and other post marketing surveillance data by examining the

data for patterns and trends and investigating when necessary.;

2. Investigates customer complaints related to product quality or patient safety.;

3. Investigates identified trends by starting a formal trend investigation and trend report and working on

cross-functional teams.;

4. Documents trend action by updating the trend report at appropriate levels and by performing

a Health Risk Analysis.;

5. Communicates product performance by formal presentations 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.;

6. Provides input for process improvement and helps develops tactical approaches to implement team strategies.;

7. Develop test plans, procedures, justifications papers and provide engineering support for new 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 developmentof 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.

Minimum Education

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.

May consider at lower level depending on experience

JOB FAMILY:

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