Senior Manager, Medical Device Quality & Complaints

Arrowhead Pharmaceuticals, Inc.; Madison (WI); On-site; USD 110,000 - 165,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. is seeking a senior Quality Assurance professional to oversee medical device QA across the QMS and to own the product complaint management for clinical and commercial combination products.

The role ensures compliance with US and international medical device regulations while collaborating with Quality, Operations, Regulatory, and Supply Chain teams. The ideal candidate will bring extensive QA experience in medical devices, strong knowledge of GxP, and a proven

Qualifications

• BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry or equivalent.
• Eight+ years of QA experience in medical device or drug-device combination products, including three years with direct QMS accountability.
• Experience with product complaint handling, investigations and root cause analysis.
• Knowledge of GxP, 21 CFR Part 4, Part 803, ISO 13485, ISO 14971, GDP.
• Experience applying design controls and risk management to devices or combination products.
• Strong organization, communication, and stakeholder influence.
• Proficient with Microsoft Word, Excel, Adobe Acrobat, SharePoint, DocuSign, and SmartSheet.
• Occasional travel may be required.

Responsibilities

• Serve as internal medical device SME for QMS and product development/support.
• Ensure compliance with 21 CFR 820, ISO 13485, ISO 14971 and other standards.
• Own the end-to-end product complaint process for clinical and commercial products.
• Coordinate investigations with suppliers and internal teams; ensure evidence-based conclusions.
• Support MDRs and postmarketing safety reports; assist vigilance reporting.
• Maintain inspection-ready complaint procedures and training materials.
• Assist in reverse distribution processes where needed.

Skills

Quality Assurance

Medical devices

GxP

Regulatory knowledge

Root cause analysis

QMS

Communication

Education

BS/BA in science or equivalent

Tools

MS Word

Excel

Adobe Acrobat

SharePoint

DocuSign

SmartSheet

Job description

Arrowhead Pharmaceuticals, Inc. is seeking a senior Quality Assurance professional to oversee medical device QA across the QMS and to own the product complaint management for clinical and commercial combination products.

The role ensures compliance with US and international medical device regulations while collaborating with Quality, Operations, Regulatory, and Supply Chain teams. The ideal candidate will bring extensive QA experience in medical devices, strong knowledge of GxP, and a proven