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.
Required Bachelor's Degree Engineering or Life Science discipline or related technical field
Required 3 years Work experience
Required 3 years Quality experience in the medical device industry
Required Other Statistical Process Control experience
Licenses and Certifications:
Required Computer knowledge and experience with Microsoft Office
Preferred Six Sigma certification
Candidate Background: Skills, Knowledge & Ability: Minimum requirements:
Required Work experience
Required Quality experience in the medical device industry
Required Statistical Process Control experience