We are a fast-growing global medical device company, developing and manufacturing innovative drug delivery and infusion solutions across the continuum of care- from the hospital to the home. We’re looking for excellent QA Director to join our QA Team.
Oversees the Quality team- Product Quality, QMS and Compliance of the company.
Act as the Management Representative. Establish periodical Quality strategic plans.
Act as a facilitator in External Audits in the company`s regional entities. Perform Internal and Supplier audits.
Responsible for all company QMS related Internal training and qualification.
Provide guidance to product development, Engineering, Ops., Service and RA teams as to the required deliverables to ensure compliance throughout product and QMS life cycle.
Responsible for engaging strong intradepartmental and cross-functional/organizational relationships to drive Quality system Requirements and any improvement needed.
Responsible for compliance of the quality system, products, and services.
Responsible for driving continuous improvements in the organization. Responsible for providing a process structure that incorporates quality points that become intrinsically linked to the process itself.
Customers contact person with regards to Quality related matters.
Areas of Authority:
Review and approve Quality system related documentation and records. Review and support activities performed by applicable Quality personnel. Issue Audit reports Review and approve CAPAs, NC, Audits Participate in applicable forums and committees- COCO, Staff, SMC, PMS, QRB and others as required.
Oversees the Quality team- Product Quality, QMS and Compliance of the company.
Act as the Management Representative. Establish periodical Quality strategic plans.
Act as a facilitator in External Audits in the company`s regional entities. Perform Internal and Supplier audits.
Responsible for all company QMS related Internal training and qualification.
Provide guidance to product development, Engineering, Ops., Service and RA teams as to the required deliverables to ensure compliance throughout product and QMS life cycle.
Responsible for engaging strong intradepartmental and cross-functional/organizational relationships to drive Quality system Requirements and any improvement needed.
Responsible for compliance of the quality system, products, and services.
Responsible for driving continuous improvements in the organization. Responsible for providing a process structure that incorporates quality points that become intrinsically linked to the process itself.
Customers contact person with regards to Quality related matters.
Areas of Authority:
Review and approve Quality system related documentation and records. Review and support activities performed by applicable Quality personnel. Issue Audit reports Review and approve CAPAs, NC, Audits Participate in applicable forums and committees- COCO, Staff, SMC, PMS, QRB and others as required.
This position is open to all candidates.