Quality Engineer (Medical)

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.

A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.

Job Summary

To support our extraordinary teams who build great products and contribute to our growth, we're looking to add a Quality Engineer, located in Tijuana.

Reporting to the Quality Manager , the Quality Engineer role involves:

What a typical day looks like:

• Develops and initiates procedures for sterilization release and validation.
• Coordination and evaluation of non-conformant product disposition related with sterilization excursions.
• Support workers engaged in monitor sterilization metrics.
• Provide training to workers related with sterilization process.
• Review and analyze bioburden and dose audits data
• Review and analyze endotoxin testing results
• Coordinate and conduct sterilization validation process for ethylene oxide and radiation methods.
• Initiates corrective action requests as needed and tracks to satisfactory completion.
• Support Engineering and Quality areas in projects where sterilization needs to be evaluated; such change of materials, change of raw material supplier locations, etc.
• Develops procedure for bioburden, dose audits and endotoxin testing.
• Coordinate endotoxin testing activities.
• Coordinate bioburden testing activities
• Determine appropriate validation, process controls and monitoring (e.g. dose audits, parametric release, process challenge device (PCD), residuals, etc.) are properly implemented to ensure Sterility Assurance Level (SAL). Ensure the process is documented in accordance with industry standards: ISO 11135, ISO 11137.
• Review and approve endotoxin, bioburden, dose audits and sterilization reports.
• Supports Product Engineers and Quality Program Managers with customer interfaces as necessary on quality-sterilization related issues.
• Coordinate sterilization validation projects through meetings with customers and sterilizers.
• Analyzes reports for returned products and recommends corrective action related with sterilization
• Make sure that bioburden and dose audits are performed on time

• Conversational and written English
• Able to use Office system: Word, Excel, Power point, etc
• Responsible
• Communicate and escalate situations on time
• Understand EO and radiation concepts
• Material identification, status, and traceability: Define and distinguish between these concepts, and describe methods for applying them in various situations.
• Material segregation: Describe material segregation and its importance, and evaluate appropriate methods for applying it in various
  situations.
• Material classification: Assess and classify product and process defects and nonconformities
• Kowledge in Quality System concepts
• Understand preventive and corrective maintenance concept
• Identify different measurement tools: caliper, rules, micrometers, spectrophotometers, etc
• Understand differences between Variables and attributes and apply them
• Distinguish bewteen nondestructive and destructive measurement test methods and how should be used
• Understand linearity, linear regression concept
• Understand Quality System elements, including planning, control, and improvement
• Understand customer requirements (Qualoity agreeement, drawings, etc)
• Understand ISO 13485, QSR
• Understand metrology techniques such as calibration, traceability to calibration standards, measurement error and its
  sources
• Understand repeatability and reproducibility (gage R&R) studies, measurement correlation, capability, bias, linearity, precision, stability and accuracy
• Define, describe, and apply the following continuous improvement methodologies: Total quality management (TQM), Kaizen, Plan-do-check-act (PDCA), Six Sigma
• Define, describe, and apply the following lean tools: 5S, Value stream mapping, Kanban, Visual control, 8 Wastes, Overall equipment effectiveness (OEE)
• Identify, describe, and apply elements of the corrective action process, including problem identification, failure analysis, root cause analysis, 5 Whys, problem correction, recurrence control, and verification of effectiveness.
• Understand probability distributions; i.e. normal, exponential, lognormal, Weibull, Student's disptribution
• Understand Process capability and performance: Cpk, Ppk
• Identify, describe, and apply various preventive action tools such as error proofing/poka-yoke, and robust design,
  and analyze their effectiveness.
• Understand Design of Experiment concepts (DOE)
• Identify and define various lean tools: 5S, standard operations, kanban (pull), error-proofing, value-stream mapping
• Identify how such analyses can indicate whether a problem is systemic or isolated
• Understand sterile barrier concept

• Pantry vouchers
• Saving Fund
• Christmas bonus
• Holiday bonus
• Medical Insurance
• Life Insurance