Quality System Engineer Ii
hace 3 semanas
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.
Job Details
Responsible for developing and ensuring implementation of quality systems, procedures, test methods, problem definitions and resolutions for existing and new products.
Assists in manufacturing quality systems, product quality and customer quality requirements. Supports product improvement projects (validation IQ, OQ, PQ activities) and supplier changes to ensure qualification are met.
Completes or may lead teams/projects related to Complaint investigation, CAPA, cost reduction, and quality system excellence. Use of TQM tools including six sigma may be required.
Conducts risk analysis as needed. Conducts internal or external audits as assigned to ensure compliance to company quality system requirements.
Develops, reviews and challenges existing quality driven test systems and procedures to assure products meet intended use. Key contributor in the design review of new or modified products. Challenge design assumptions to assure design intent
Manufacturability and customer acceptance levels are achieved and in compliance with Haemonetics SOPs and regulatory standards.
Maintains records to ensure compliance to GMP/ISO requirements.
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