Quality Engineer - Queretaro Site

at  Abbott Laboratories

REQUIRED QUALIFICATIONS

• Education.- Bachelor Degree (University Level) in STEM (Science, Technology, Engineering (preferred), (experience in medical devices or pharmaceutical quality control preferred)

EXPERIENCE

• 4-6 years’ experience in Quality or Engineering positions.
• At least 4 years of experience in Quality or Manufacturing Engineering positions.
• Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
• Knowledge of statistical/data analysis and report writing experience.
• Experience with control of nonconforming material, corrective and preventive actions as investigation owner and/or implementor.
• Experience working on FDA, GMP, and ISO 13485 Regulated environments.
• Experience in process improvement tools such as: Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma or Process Control & Monitoring (SPC), Quality Tools.
• Project management experience, participating or leading multi-departmental project teams.

PREFERRED QUALIFICATIONS & EDUCATION

• ISO 13485 certification as Lead Auditor or similar
• Experience with SAP.
• ASQ CQE / Six Sigma certification or similar.
• Participation or leading multi-departmental project teams.
• Experience in supervision role.
• Available to travel long period for training

• Verify company’s adherence to the established Quality System and GMP/ISO standards.
• Provide support and coaching to lower-level engineering positions and guidance to other areas of the organization on Quality related topics
• Completion of risk management and risk analysis including FMEA.
• Work with R&D/Design 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.
• Own NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process
• Works closely with Sr quality position on completing and documenting Monthly Quality Data Review, providing data analysis and escalation recommendations.
• Leading Build At Risk (BAR) Authorizations, approvals& Closures
• Own, complete or approve of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements
• Creation and maintenance of Quality Plans and Reports. Also, provide support to lower level engineering positions.
• Own, execute, review or approve of IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, and mentorship from higher level engineering.
• Conducting Advanced Statistical Data Analyses using Minitab.
• Authoring Master Validation Plans and Reports / Quality Plans and Reports.
• Supports activities during preparation and execution of audits (External / Internal), functioning as SME backup for specific Quality activities.
• Support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.)
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Support, coach, and mentor non-exempt and entry level exempt personnel.
• Creating and Communicating details and information of events related to quality to upper management.
• Participation as listener and presenter on management meeting such as QDR, KPIs and Management Review.
• Perform other duties and responsibilities as assigned by senior management.
• Perform supervisor activities to Quality Technicians, if required.