הרשמה לניוזלטר

Sr. Production and Supplier Quality Engineer

דרוש/ה

For a successful Medical Devices company we are looking for Sr. Production and Supplier Quality Engineer

עיקרי התפקיד

  • responsible for driving exceptional product quality for the patient safety, customer value beyond expectations, regulatory assurance, and optimized Cost of Quality for org. This is a key technical position, affecting part quality for both installed base and NPI parts.

  • Develop, administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements

  • Improve supplier quality performance for assigned suppliers.

  • Lead supplier audits as required by org supplier audit schedule and supplier performance management requirements

  • Perform supplier qualification processes - including quality requirements definition & communication, control plan negotiation, COT definition, etc…

  • Participate in supplier selection process and specification reviews with suppliers to ensure that purchased components/materials meet org specifications

  • Assure supplier compliance to org QMS and regulatory requirements through supplier monitoring process.

  • Ongoing supplier’s evaluation & monitoring – source inspections, statistical analysis.

  • Specify quality characteristics and inspection plans for components, subassemblies, and finished devices

  • Develop positive relationships and work closely with Sourcing Leaders to manage and implement supplier/engineering changes, New Product Introductions, and transfers.

  • Lead and collaborate with cross-functional teams to manage supplier change notifications through risk based evaluation

  • Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested

  • Interface with Suppliers, Engineering, Service, Manufacturing and Sourcing to drive Quality improvements that minimize the Costs of Quality, specifically Failed on Arrival/Install (DOA/RMA) issues, Field Failures, and Factory defects.

  • Assure Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with the CAPA process.

דרישות התפקיד:

  • Fundamental knowledge of ISO13485:2016 and FDA requirements for medical device industry

  • Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally).

  • Ability to work independently with minimal supervision

  • Computer skills (Microsoft Word, Excel, PowerPoint)

  • Working knowledge in Statistical Tools (Measurement Systems Analysis, Process Capability and Statistical Process Control)- preferred

  • Knowledge of various quality system methodologies Lean, 5 Why’s, DFMEA, PFEMA, PPAP, etc.- preferred

  • Strong written and verbal communication skills in English

  • Strong organizational skills

  • Bachelor's Degree in an engineering or equivalent applicable experience

  • 3 years of experience in production and supplier quality engineering in medical device industry or highly regulated industry


להגשת מועמדות ומידע נוסף - לחץ/י כאן

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