SR. QUALITY ENGINEER

at  Abbott Laboratories

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 114,000 colleagues serve people in more than 160 countries.

MINIMUM EDUCATION

Bachelor’s degree (Engineering/Life Sciences) plus 6+ years of related work experience with a strong
understanding of specified functional area, or an equivalent combination of education and work
experience.

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.;

Candidates / incumbents should possess the following:

• Medical Devices experience preferred
• Experience working with Quality Systems
• Data Analysis experience
• Risk Management experience
• Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical devices;
• Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior;
• Ability to work independently and in groups; ability to work cross-functionally;

ability and aptitude to use various types of databases and other computer software;

• Ability to prioritize;
• Strong organizational and project management skills;
• Ability or aptitude to lead without direct authority.

(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.

WHAT YOU’LL DO:

Primary Job Function
Serves as liaison between internal Abbott third party manufacturers and Abbott Vascular. Ensures effective implementation of quality and compliance requirements between multiple quality systems and sites.

Core Job Responsibilities

• Work requires collaboration with other sites and other Abbott divisions;
• Responsible for implementing and maintaining an effective Quality System.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Responsible for implementing and maintaining an effective Quality System;
• Independently lead groups and projects to resolve complex issues; analyze complex problems and identify their impact; establish probabilities; draw conclusions reflecting broad business needs; ensure compliance;
• Cross-functionally lead Quality System process improvements which may include training,
• corrective action and preventive action (CAPA) activities, equipment maintenance, product and process
• planning, quality audits, validation;
• Responsible for completing documentation in a timely manner and in accordance with business standards;
• Travel up to 10% of the time both domestically and internationally by any means necessary to support organizational goals;
• Prepares metrics data
• Supports audit and audit readiness activities
• Other tasks and duties as assigned;

(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.