Abbott Sr. Standards Engineer 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.
The Sr. Quality Compliance Engineer ensures that Abbott Vascular products maintain compliance with US and foreign regulation and declared standards and provides constructive evaluation of test protocols and reports to conclude and provide evidence of conformity.
Their leadership in the area of GCP, GLP and GMP compliance will assure that activities are performed and documented per our systems and procedures in accordance with Abbott policies and applicable quality and regulatory requirements intended to assure the effectiveness and safety of our products.
The responsibility of this function is to lead efforts to assesses the compliance of Abbott Vascular products and processes per applicable regulations and standards.
This is executed through managing the following activities:
Analyze global regulations and applicable standards and drive creation of formal External Requirements Plans in support of Research and Developement.
Lead crossfunctional teams of SMEs to complete detailed assessment of new or revised regulations and applicable standards.
Initiate appropriate changes to External Requirements Plans for all AV product families and coordinate with SMEs when additional testing or data is necessary to support Declarations of Conformity.
Coordinate with Regulatory Affairs on maintaining current Declarations of Conformity in sync with External Requirements Plans.
Serve as a CAPA System Subject Matter Expert, identify necessary preventive actions to stay in compliance with external requirements, as well as teaching other CAPA Users at all levels how to conduct assessments.
Conduct CAPA investigation and able to judge the quality of investigations based on technical knowledge, tracks issues through to closure including reviewing the corrective action taken.
Problem solving and decision making for investigations:
Monitors compliance of company policies and procedures with regulatory requirements (e.g. compliance with FDA, EMEA, CALA and APAC and emerging market regulations and standards etc).
Monitors external sources of information to identify applicable regulations and standards and determine necessity of AV product conformity.
Support internal and external audits as subject matter expert for sustaining state of the art conformity during the product lifecycle.
The position serves a strategic purpose for Abbott and must achieve a balance of involvement and objectivity,
Demonstrate appropriate risk-based decision making, and prioritize key activities to maintain product conformity and GMP/QMS compliance.
The position also provides an active role within the Corporation as Divisional experts in external regulatory requirements and applicable standards.
Education / Experience
Bachelor's degree and 5+ 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.
(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.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org