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Engr, Quality

Description

Create the structure of the PMC project support team for Guadalajara since the product introduction and launch phase including mass production with an Engineering focus on quality and processes.

What You Will Do In Your Role

  • Support customer satisfaction at the same level as a Medical high level OEM requires.
  • Analyze systematically the in front data and exercise discoverability under the unknown scenario and based on this develop failure analysis , drive corrective actions and even design from a concept or draft,a product and a process improvements identifying the best ROI (return of investment) with the highest level of quality and safety.
  • Participate actively on the design of tooling for the products from the zero defect mentality.
  • Accomplish with industry requirements and internal Molex procedures.
  • Provide proper balance to the process engineering with a strong technical knowledge and required background over the complexity of the electronic industry product offering.
  • Lead continuous improvement with a clear understanding of the timelines, communication and the ability to get the team members coordinated.

Experience:

  • High level understanding n ISO 13485 &FDA including 21 CFR part 820 industry standars.
  • Solving tools proficient user (5 Why´s, Ishikawa diagrams, brain storming, etc).
  • Proficient user of statistical tools while not Minitab or other software for this purpose.
  • Strong understanding & frequent developer for APQP & PPAP requirements & documents and / or equivalent.
  • Has personal experience on developing MVP (master validation plan) including IQ, OQ and PQ elements of a process validation.
  • Expert or at least have well understanding on manufacturing and process engineering for PCB electronics environment.
  • Strong LEAN thinking conveying to zero defects / zero wastes (Kaizen tool).
  • Program management understanding – collaboration and having strong strategy mental model.


What Will Put You Ahead

  • 5 years on similar position (min) in manufacturing Medical industry / environment. Proven experience in all mfg manufacturing supply chain from quality planning to mass production.
  • Experience on supporting medical product launchings and / or mass production product transfers from the ISO 13485 and FDA compliance.
  • Proven experience on reviewing and closing gaps versus customer specific requirements.
  • Has actively participated in regulatory agency for medical and customer system and product audits based on standards fulfilling Audit requirements under audit time pressure and closing pending items afterwards.
  • Customer focus oriented thinking (Failure analysis, Corrective actions, etc) on constrained time-frames.

Education

  • Bachelor in Electrical, Mechanical Engineering or similar
  • English fluent, professional level


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