Abbott Quality Engineer in Alajuela, Costa Rica
Position Summary :
Works closely with development/manufacturing to establish/ensure compliance with the quality system. Works closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance. He/she establishes/monitors quality assurance efforts to ensure that the company’s products conform to quality standards. Works with research/development and manufacturing engineering during new product start-ups and establishes checkpoints for testing new products and processes.
Provides Quality Engineering Body of Knowledge support to company and organization.
Verify company’s adherence to the established Quality System and GMP/ISO standards.
Work with Engineering, Manufacturing, Laboratories and Regulatory to establish measurable, valid product requirements.
Aide in definition of test equipment as required accomplishing quality responsibilities.
Develops and documents test plan protocols, test procedures, and test reports, typically with mentorship from higher level engineering.
Perform tests according to various protocol requirements.
Assist in completion of risk management and risk analysis including FMEA.
Assist in completion of customer complaint related investigations.
Work with R&D to devise design verification and design validation plans for products based on performance specifications and risk analysis.
Analyze and communicate conformance to specifications and standards.
Conducts technical and statistical investigations concerning optimization and compliance to specification.
Assist in measuring process capability, process controls, and process validation. Assist in definition of CTQ parameters.
Aide in definition of sampling plans and inspection methods.
Assist in specifications and testing of sterilization methods.
Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
Perform other duties and responsibilities as assigned by senior management.
Bachelor Degree required in Engineering, Technical Field, or Bachelor Degree in Business Administration with at least 5 years experience in Quality Engineering positions.
Intermediate command of English.
Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
At least 5 years of experience in Quality or Manufacturing Engineering positions.
Knowledge of statistical/data analysis and report writing skills.
Experience on Quality tools/methodologies.
Knowledge of FDA, GMP, and ISO 13485.
Experience in process improvement tools such as: (Root Cause Analysis, Fishbone, Is/Is Not, etc.), Six Sigma or Process Control & Monitoring (SPC).
Knowledge on product and process qualification and validation.
Experience with control of nonconforming material, corrective and preventive actions.
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