Bachelor’s degree in engineering function
Determine and define quality assurance requirements from review of engineering drawings and/or specifications, industry standards, government specifications or other applicable source documents.
Formulate, write and maintain procedures, specifications and standards for the quality control of Alliance products including non-destructive testing methods, gauge design and procurement, sampling and inspection methods and visual acceptance standards.
Coordinate the maintenance of the calibration program for all inspection tools and gauges to comply with division and corporate Good Manufacturing Practices.
Develop and administer effective data collection and reporting system to meet regulatory requirements and management information needs.
Control further processing, delivery or use of nonconforming products until deficiency or unsatisfactory condition has been corrected.
Provides resources, including the assignment of trained personnel for performance of work and assessment activities to meet requirements.
Implement defect prevention strategies utilizing SPC/SQC principles and practices.
Provides technical and administrative guidance to Quality Assurance, Manufacturing, and suppliers of raw materials or finished medical devices. Assures product conformance to established requirements and standards through appropriate inspection and test activities. Coordinates quality planning, inspection method development and defect prevention/corrective action processes for new and existing products. Identifies and solves product and process problems and supports various operational groups. Assists in the preparation and monitoring of the operating and capital budgets.
Over 3 years of experience as a quality professional (orthopedic/spine background preferred)
Over 1 years of experience managing quality teams (orthopedic/spine background preferred)
ASQ certifications (CQA, CQE, CQM), preferred
Experience in the following areas preferred:
Incoming inspections, in process testing, final release of products, final release testing, overseeing all batch records for each product, ensure that all FDA and ISO requirements are met, management reporting of all quality metrics, update quality procedures and processes.
Send resumes to email@example.com