Job Description Summary

To direct and maintain site's Supplier Management Program as required, in compliance with ISO, QSR
FDA standards, other international standards.

Job Description

Job Responsibilities:

Drives the site's Supplier Quality functions, assuring the development of the Quality System and
the compliance to corporate Standards, FDA, QSR’s, ISO 13485 among other requirements.
• Provide direct supervision and/or technical guidance to SQE, Sr. SQE, Supervisors, Clerk,
Leaders, IQC inspectors and interns as applicable.
• Plan and coordinate supplier quality activities and resource requirements.
• Plan / Supervise and approve Supplier/Component Qualifications to meet requirements.
• Assure the availability of current product drawings, specifications, and visual inspection boards.
• Approve the plan to implement and modify, as needed, the Quality Control inspection, audit plans,
test procedures for incoming components.
• Organize, manage and train Supplier Quality employees to execute the full scope of supplier
quality program.
• Assure conformance to good manufacturing practices in the supplier department.
• Develop quality assurance training standards and assure that the SQE group is trained.
• Lead continuous improvement projects to increase effectiveness of Supplier Quality System
department.
• Promote, support plant continuous improvement program activities; contribute ideas to these
programs and work on implementation. Support to committees, teams, task forces, etc. as
assigned.
• Exercise control over the quality of conformance of the components inspected. Assure component
conformance to all design and quality system specifications and requirements included in the
drawings.
• Initiate SCARs, when necessary, follow up on complaints, quality rejects and scrap levels related
to supplier quality. Lead problem solving, failure analysis and CAPAs until effective problem
solving

• Coordinate and administer Supplier Audits and Assessments according to schedule.
• Lead or participate on supplier management committee (SMC) and teams as assigned.
• Maintain, generate, and evaluate supplier performance metrics and reports.
• Conduct Supplier development as needed.
• Provide support to Production, R&D, Engineering and Quality Assurance Departments on
component related issues.
• Execute key supplier audits in response to significant performance issues that may jeopardize
product's quality or compliance to standards.
• Perform Internal Quality Audits to support annual audit schedule, as necessary.
• Prepare and implement Corporate Standards procedures or policies related to supplier audits or
evaluations activities.
• Executes other duties assigned by the supervisor.
• Mandatory compliance to general and safety procedures applying to this position.
• The Supplier Quality Mgr has the authority to:
• Place suppliers on Limited or Approved with Control status, recommend and promote
supplier’s disapproval when applicable.
• Hold, retain, reject, or release materials.
• Interface with suppliers to assure:
• They receive and understand specification requirements for the items to be supplied.
•They have adequate facilities and personnel for manufacturing and controlling quality of
their material.
•That supplier takes appropriate action to correct quality deficiencies.
• Provide reports to the Quality Director of the status of product component quality.

Education and Experience:
• Bachelor’s in engineering sciences
• Minimum 5 years’ experience in supplier / quality systems, or management in medical devices
industries position.
• Experience on Quality Systems (FDA-CFR), GMP’s and ISO 13485.

Knowledge and Skills:
• Six Sigma Green Belt Certification or CQE certification.
• Certified Lead Quality Auditor.
• Experience applying problem solving techniques (i.e., Six Sigma, 8D's, etc).
• Experience on quality systems requirements and application of statistical techniques (Control
charts, sampling plans, design of experiments, etc.).

Required Skills

Optional Skills

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Primary Work Location

MEX Juarez Healthcare

Additional Locations

MEX Juarez Homecare

Work Shift