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 dont 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 were 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

The experience were looking to add to our team:

• 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 Students 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

What youll receive for the great work you provide:

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

HS115

Job Category

Required Skills:

Optional Skills:

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit qualifications and abilities. We do not discriminate based on: age race religion color sex national origin marital status sexual orientation gender identity veteran status disability pregnancy status or any other status protected by law. Were happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email and well discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex you must complete the application process first).