Seeking a hands‑on
Director of QA/RA
to own the Quality Management System and Regulatory strategy for a Class II HW/SW medical device company. This is an ideal role for a Manager/Senior Manager who is looking for their next step up to Director level.
Key Responsibilities
Quality Management:
Full ownership of QMS maintenance and Post‑Market via
QT9 (eQMS/ERP) .
Design Quality:
Direct Design Controls, Risk Management, and NPD for electromechanical systems.
Regulatory:
Lead US 510(k) strategy; partner with external consultants and author/review technical documentation.
Supplier Quality:
Manage ~50 suppliers; oversee the transition of new products to a contract manufacturing model over the next 18 months.
Team Leadership:
Direct management of two reports initially
Requirements
6–12 years
in MedTech QA/RA.
Direct experience with
Class II Electromechanical (HW/SW)
products.
Strong working knowledge of
Design Controls
and
510(k)
submissions (submission authorship not required)
Prior experience in supplier management and QMS maintenance.
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Director of QA/RA
to own the Quality Management System and Regulatory strategy for a Class II HW/SW medical device company. This is an ideal role for a Manager/Senior Manager who is looking for their next step up to Director level.
Key Responsibilities
Quality Management:
Full ownership of QMS maintenance and Post‑Market via
QT9 (eQMS/ERP) .
Design Quality:
Direct Design Controls, Risk Management, and NPD for electromechanical systems.
Regulatory:
Lead US 510(k) strategy; partner with external consultants and author/review technical documentation.
Supplier Quality:
Manage ~50 suppliers; oversee the transition of new products to a contract manufacturing model over the next 18 months.
Team Leadership:
Direct management of two reports initially
Requirements
6–12 years
in MedTech QA/RA.
Direct experience with
Class II Electromechanical (HW/SW)
products.
Strong working knowledge of
Design Controls
and
510(k)
submissions (submission authorship not required)
Prior experience in supplier management and QMS maintenance.
#J-18808-Ljbffr