Description
Provide QA technical and compliance expertise as part of development teams in establishing and assuring product quality objectives. Assure compliance to applicable regulations. Perform quality activities such as risk management, verification and validation, audits support, procedure development, product release, documentation review and define changes to controlled documents.Plans, executes, reports and follows-up on quality system audits (supplier and internal)
Actively participates on cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations
Monitors compliance with company policies, procedures and applicable regulatory requirements
Experience with document control, CAPA, and complaint investigation
Qualifications
Bachelor's Degree in Engineering, Chemistry, Biology or related science/technical field or an equivalent combination of education and work experience.
3-5 years experience in the medical device industry.