Irow9
The Quality Engineer supports the Regulatory Affairs organization by driving audit preparedness, KPI and management review metrics, quality system improvements, and post-approval commitment tracking. The role focuses on risk identification, mitigation, and cross‑functional coordination to meet compliance requirements.
Responsibilities
Drive KPI dashboards, RA management review metrics, and internal reporting.
Manage RA audit preparedness, including risk identification, mitigation, CAPAs, and preventive actions.
Support QMS audits, audit backrooms, and development of auditing plans and mock audits.
Support quality system integration for acquisitions and new product introductions.
Maintain and improve_ADDRESSadium system procedures, including change management.
Track regulatory post-approval commitments and support RA projects.
Identify and implement system and process improvement initiatives.
Liaise with cross-functional teams and international affiliates to drive complianceâte and issue resolution.
Required Skills
Ability to work independently and manage multiple workstreams.
Strong troubleshooting and critical thinking skills.
Ability to drive issues through resolution and implement mitigations.
Preferred Skills
Exposure to Medical Device US and CE regulations.
Experience with Quality Systems, Compliance, or Regulatory Affairs support roles.
iROW9 Inc. 6045 Kimberly Lane N, Plymouth, MN USA 55446
+1 (612) 636-0037
iROW9 Pvt. Ltd #J-18808-Ljbffr
Responsibilities
Drive KPI dashboards, RA management review metrics, and internal reporting.
Manage RA audit preparedness, including risk identification, mitigation, CAPAs, and preventive actions.
Support QMS audits, audit backrooms, and development of auditing plans and mock audits.
Support quality system integration for acquisitions and new product introductions.
Maintain and improve_ADDRESSadium system procedures, including change management.
Track regulatory post-approval commitments and support RA projects.
Identify and implement system and process improvement initiatives.
Liaise with cross-functional teams and international affiliates to drive complianceâte and issue resolution.
Required Skills
Ability to work independently and manage multiple workstreams.
Strong troubleshooting and critical thinking skills.
Ability to drive issues through resolution and implement mitigations.
Preferred Skills
Exposure to Medical Device US and CE regulations.
Experience with Quality Systems, Compliance, or Regulatory Affairs support roles.
iROW9 Inc. 6045 Kimberly Lane N, Plymouth, MN USA 55446
+1 (612) 636-0037
iROW9 Pvt. Ltd #J-18808-Ljbffr