Abbott Staff Analyst - Quality Systems in Temecula, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Primary Job Function Establish and maintain effective structures to ensure consistent implementation of quality systems at Abbott Vascular. Create processes and process improvements to ensure consistent
implementation of internal requirements and external laws, regulations, guidances and
Core Job Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Identify internal requirements and external laws, regulations, guidances
and standards (LRGS) applicable to one or more of Abbott Vascular's
- Interpret applicable internal requirements and external LRGS and incorporate
into requirements for use in Abbott Vascular business processes.;
Identify areas of potential noncompliance within Abbott Vascular.;
Review and update the Quality System Manual as needed.;
Educate functional areas on quality system requirements.;
Participate cross functionally and cross business units to standardize
Abbott Vascular business quality system policies and procedures.;
- Mediate resolution of interdepartmental and cross business unit process
Identify qualified externalconsultants and experts in government, collaborating with them to insure correct interpretation of LRGS.;
Collect business process data from different parts of the company for
Act as an expert resource in specific LRGS requirement knowledge for Abbott Vascular.;
May be responsible for identifying training requirements, programs, and
Supervisory / Management Responsibilities
(Supervision Received) Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment.
Completed work is reviewed from a relatively long-term perspective, for desired
(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) Understands business environment and relates extensive knowledge of internal and external activities to trends. Interfaces with a variety
of management levels on significant matters, often requiring the coordination
of activity across organizational units.
Participates in the development of others by facilitating training and providing
feedback and guidance. May lead a project team. Provides technical leadership to business units. Acts as a mentor to less experienced
staff. Exercises judgment independently.
(Planning/Organization) Plans and organizes project assignments of substantial variety and complexity. Initiates or maintains schedule for projects and project
milestones. Establishes priorities of individual or project assignments.;
(Decision Making/Impact) Selects methods and techniques to lead a project to completion. Erroneous decisions or recommendations would typically result in
failure to achieve organizational objectives.
Bachelor's degree (Science/Technical) plus 9+ years of related work experience
with a complete understanding of specified functional area, or an equivalent
combination of education and work experience. Advanced degree preferred.
Minimum Experience / Training Required
** Medical Device/Pharma experience preferred
** Manufacturing experience preferred
** Project Manager Certification preferred
** Project Manager experience preferred.
** Supervisory experience a plus.
(Technical/Business Knowledge (Job Skills)) Comprehensive knowledge and application business concepts, procedures and practices. Uses in-depth knowledge
of business unit functions and cross group dependencies/relationships. Is
recognized as an expert in work group. 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 complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly
defined practices and policies in selecting methods, techniques and evaluation
criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business.
TRAVEL UP TO 10% - SOME INTERNATIONAL.
NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION.
OPEN TO CONSIDER CANDIDATES AT A LOWER LEVEL FOR THIS POSITION.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com