Job duties

:

Responsible for tasks related to on-going quality programs; quality System development and implementation, validations and process development, design change, corrective and preventive action, change control, and quality audits to ensure that assigned Luminex products meet established specifications, design criteria and control, quality and regulatory standards and customer requirements. Will trend quality data, evaluate risk and make proposals for continuous improvement. Act as a leader and a mentor; Provide inputs to process validation activities and process risk decisions (PVMP/PFMEA); Review, consult, and approve validations and equipment/instrument qualifications (IQ, OQ, PQ, Process, off-the-shelf software, etc.); Review, consult, and approve design change activities; Evaluate deviations, non-conformances, out of specifications, customer complaints and process change controls for completeness and impact on product quality; Review, consult, and approve risk analysis; Conduct or serve as a lead/coordinator of investigations for corrective and preventive action (CAPA); Prepare and trend data/materials for meetings and present; Participate in audits and inspections; Participate in various review boards as required, example Supplier Review board, Material Review board; Collaborate with operations on the implementation of process controls and improvements; Write and/or implement changes to controlled documents as needed; Investigate and collaborate with other departments to resolve quality issues; Provide day-to-day guidance and training to other QA personnel, as required; Support Quality system training and participates in the development of training programs regarding all aspects of producing quality products; Review records and data for product release; Leader in Quality system continuous improvement activities; Quality Representative in new Product Development core teams; Mentors personnel to continuously enhance the companys quality culture; Support and participate in other QA related activities as required.

Education and Experience

: Masters degree in Industrial Engineering or a closely-related field or the foreign educational equivalent, plus three (3) years of relevant experience. Up to 10% domestic travel may be required.

How to Apply:

To apply for this position, please send your resumes via email to

avaughn@luminexcorp.com

referencing the position title above.

Luminex Corporation is an EOE.