a global medical device company is looking for QA Manager
Managing global compliance audits
Oversee the Design Control, Design transfers, process improvements, and general operations.
Process owner for document control activities
Responsible for internal and supplier auditing.
Lead the (CAPA) teams in response to concerns identified through complaints, non-conforming materials, and other relevant processes.
Represent Quality Assurance in the Change Control Board (CCB) meetings to review and disposition
Engineering Change Orders (ECOs).
Requirements:
Engineering Bachelor's Degree, Bio-Medical Engineer is preferred, or an equivalent number of years of experience.
Minimum 6-10 years of experience in Quality in a regulated industry (Medical Device is mandatory).
Experience working with Notified Bodies and audit preparation.
Experience with ISO 13485, 21 CFR 820, MDR, and Quality Systems Regulation is mandatory.
Ability to prioritize, and work in a multi-task environment
Engineering Bachelor's Degree, Bio-Medical Engineer is preferred, or an equivalent number of years of experience.
Minimum 6-10 years of experience in Quality in a regulated industry (Medical Device is mandatory).
Experience working with Notified Bodies and audit preparation.
Experience with ISO 13485, 21 CFR 820, MDR, and Quality Systems Regulation is mandatory.
Ability to prioritize, and work in a multi-task environment
This position is open to all candidates.
