Abbott Manager, Quality in Alajuela, Costa Rica
Position Summary :
This position is responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations. This individual develops and executes the required strategies and plans to improve product and process quality in order to deliver planned business results and assure compliance with FDA and ISO regulations and any country specific regulation were product is distributed. This position is responsible for collecting and documenting management review information, conducting regular meetings, and reporting the information to the plant’s leadership team and the appropriate Divisional Management Representative.
Bachelor's degree in Engineering, Science or Technical Field, or Bachelor's degree in Business Administration with at least 7 years of experience in Quality Engineering roles.
7+ years of experience.
Excellent English and communication skills required
Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies required
Solid knowledge of and experience working with international quality regulations, including US 21 CFR 820 (QSR) and ISO 13485
Demonstrated and impactful experience with product and process qualification and validation, process improvement, lean and six sigma methodologies, process control and monitoring (SPC)
Demonstrated results in nonconformance management and reduction, value improvement, risk reduction, and cost containment
Demonstrated organizational influence to include, but not limited to: compliance excellence, organizational improvement, product-related risk mitigation, and/or manufacturing cost reduction
Ability to travel to support domestic and international manufacturing sites (up to 15%)
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