• Quality Engineer Jobs in Costa Rica

  • Abbott India Ltd
  • Costa Rica

Job Description:

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 companys 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

Essential Functions

Provides Quality Engineering Body of Knowledge support to company and organization
Verify companys 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 on device 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

Qualifications

Bachelor Degree required in Engineering, Technical Field, or Business Administration
5 years experience in Quality Engineering positions
Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint)
At least 3 years of experience in Quality or Manufacturing Engineering positions
Knowledge of statistical/data analysis and reporting
Strong documentation and 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
Intermediate to advance command of English required

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Manufacturing/Industrial
Functional Area : Quality/Process Control
Role : Quality Assurance
Salary : As per Industry Standards
Deadline : 15th Mar 2020

Key Skills:

Company Profile:

Company
Abbott India Ltdarfix

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