About the role

  • Supplier Quality Engineer at Heraeus Medevio responsible for supplier compliance and quality processes ensuring raw materials meet specifications. Supports continuous improvement and audits supplier quality standards.

Responsibilities

  • Organize and control the supplier quality process ensuring the raw materials accomplish the specifications and regulatory conditions allowing the continuity of the business and meet customer expectations
  • Analyze and check the manufacturing processes for suppliers to promote the improvement in alignment with customer requirements
  • Ensure all suppliers and the materials are in compliance with customer requirements according to specifications to compliance with customer requirements or legality for the manufacture of medical devices
  • Provide primary support for the Nonconforming material Supplier Corrective Actions Request (SCARS) which includes but is not limited to disposition, investigation, CAPA/Corrections, and customer communication assuring the non-conforming raw material has correct disposition
  • Supervise Good Receipt Incoming Inspection, including equipment and regulatory documentation ensuring the raw material accomplishes customer requirements
  • Analyze change controls requested by customers to ensure that the requests are in a timely manner according to standards
  • Keep the tools and equipment needed assuring Incoming Inspection process works without interruptions
  • Perform quality auditing activities including external audits, supplier audits, and internal company audits to ensure the raw materials comply
  • Keep an adequate organizational environment to promote the values and Culture of HMCR
  • Support current and future business needs through the development, engagement, motivation, and preservation of human capital
  • Provide the necessary support to manufacturing area when there is discrepancies in Raw Material or Outsource Service to investigate the scope and evaluates the process controls to determine risk and actions.

Requirements

  • Bachelor's degree in Engineering discipline or related
  • Specialized knowledge in Supplier Management and Incoming Inspection and related areas
  • Negotiation skills to drive different criteria from multidisciplinary teams
  • Fluent in spoken and written business English and Spanish
  • Understanding of CAPA, statistical analysis, SPC, and Lean tools
  • Proficient with Microsoft Office
  • 5+ years of experience in related positions including Supplier Management, Change Control, and Incoming Inspection process
  • 5+ years managing Quality controls (SOPs, Work Instructions, specifications, guidelines)
  • Proficient in using Quality Management Systems and ERP solutions
  • ASQ certified Quality engineer is a plus
  • ISO 13485:20XX auditor is a plus.

Benefits

  • N/A

Job title

Supplier Quality Engineer

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Tech skills

Location requirements

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