Quality Engineer llI Temporal

Título del trabajo: Quality Engineer llI Temporal

Compañía: Manpower

Descripción de funciones: MAIN PURPOSE OF ROLE
Works closely with Manufacturing and Engineering on sustaining activities to ensure compliance with the quality system requirements and achievement of
Key Performance Indicators i.e. NCMRs, MAs, Yield, Cost Reduction projects, etc. and supportowns processproduct validation activities. Works closely with Research and Development and Regulatory Affairs personnel internal or external to obtained support on sustaining activities and during new product introduction to assure compliance with product and regulatory requirements. Support of Major Quality System investigations i.e. CAPAs, HHEs, StopShip, etc. and audits External Internal.MAIN RESPONSIBILITIES
Verify companys adherence to the established Quality System and GMPISO standards.
Completion of risk management and risk analysis including FMEA.
Work with RDDesign Quality to revise design verification and design validation plans for products based on performance specifications and risk analysis.
Conducts technical and statistical investigations concerning optimization and compliance to specification.
Owner of measuring process capability, process controls, and process validation efforts.
Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
Conducting NCMR Investigations, Calibration Out Of Tolerance OOT Investigations and Complaint Investigations MA related to manufacturing Process
Completing and Documenting Monthly Quality Data Review, providing data analysis and escalation recommendations with minimum mentorship from higher level engineering.
Leading Build At Risk BAR Authorizations Closures
Completion and approval of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements
Creation and maintenance of Quality Plans and Reports, typically with minor mentorship from higher level engineering.
Executing and authoring IQ, OQ, PQ, andor PPQ Qualifications and Inspection and Test Method Qualifications, typically with minimum mentorship from higher level engineering.
Conducting Advanced Statistical Data Analyses using Minitab with minimum mentorship from higher level engineering.Authoring Master Validation Plans and Reports
Supportowns Major Quality System investigations i.e. CAPAs, HHEs, StopShip, etc. with minimum mentorship from higher level engineering.
Supports activities during preparation and execution of audits External Internal
Perform supervisor activities to Quality Technicians, if required.ExperienceBackground
At least 2 years of experience in Quality or Engineering positions.
Proficiency in computer applications MS Excel, MS Word, MS PowerPoint.
Knowledge of statisticaldata analysis and report writing experience.
Experience working on FDA, GMP, and ISO 13485 Regulated environments.
Experience in process improvement tools such as Root Cause Analysis, Fishbone, IsIs Not, Six Sigma or Process Control Monitoring SPC, Quality Tools.
Experience with control of nonconforming material, corrective and preventive actions as investigation owner andor implementor.
Knowledge on product and process qualification and validation.Education
Bachelor Degree STEM Science, Technology, Engineering preferred, Math with equivalent experience in medical devices or pharmaceutical quality controlLanguage
Proficiency Intermediate Commands of English Required Capable of maintain fluent oral communication face to face or by conference.
Preferred Qualifications Education
ASQ CQE Six Sigma or similar certification.
Participation or leading multidepartmental project teams.
Experience in supervision role.

Ubicación: Alajuela

Fecha del trabajo: Sun, 24 Nov 2024 01:42:41 GMT


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