Supplier Quality Manager responsible for ensuring compliance with quality standards in medical devices. Leading supplier quality initiatives and supervising quality assurance teams in Juarez, Mexico.
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.
Requirements
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.
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.).
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