...the preparation and execution of validation activities, such as process validation, equipment/utilities/facilities qualification, sterilization validation and cleaning validation.
* Act as a key member of multi-department teams as the Validation Subject Matter Expert (SME...
...instructions in performing repetitive tasks.
Attentiveness in performing tasks.
Ability to work as a team member in assembling sterile medical products.
Ability to meet line rate expectations.
Manufacturing/Production experience is essential.
COMPETENCIES...
...five years’ experience in the creation of regulatory submissions for premarket approval is required.
Experience of FDA guidance for sterile implantable products in premarket approvals is desirable.
Technical competency of ISO13485:2016, ISO 14971, MDR 2017/745, and the...
...five years’ experience in the creation of regulatory submissions for premarket approval is required.
Experience of FDA guidance for sterile implantable products in premarket approvals is desirable.
Technical competency of ISO13485:2016, ISO 14971, MDR 2017/745, and the...