**Job Description Summary**: To direct and maintain site's Supplier Management Program as required, in compliance with ISO, QSR
FDA standards, other international standards.
**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.
- 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.
charts, sampling plans, design of experiments, etc.).
**Required Skills**:
Optional Skills

**Primary Work Location**: MEX Juarez Healthcare
**Additional Locations**: MEX Juarez Homecare
**Work Shift**:

📌 Supplier Quality Manager (Ciudad Juárez)
🏢 Bd
📍 Ciudad Juárez