Senior Medical Device Quality & Complaints Lead

Arrowhead Pharmaceuticals, Inc.; Verona (WI); On-site; USD 150,000 - 165,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Verona, WI seeks a Medical Device Quality Assurance lead who acts as SME for the QMS and owns the product complaint management process for clinical and commercial combination products.

You will ensure compliance with 21 CFR 820, ISO 13485, ISO 14971, and related regulations while guiding cross‑functional teams through design controls and lifecycle documentation. This full‑time onsite role reports to the Director, Supplier Quality and collaborates with Quality,

Qualifications

• BS/BA in chemistry, biology, biochemistry, or related field.
• 8+ years QA experience in medical device or drug-device combo products.
• Experience with product complaint handling and root-cause investigations.
• Knowledge of GxP, 21 CFR parts, ISO 13485, ISO 14971, EU MDR, GDP.
• Experience with design controls and DHF/DMR documentation.
• Strong communication and stakeholder influence skills.

Responsibilities

• Serve as internal medical device SME for QMS and development/commercialization of combination products.
• Ensure compliance with 21 CFR 820, 21 CFR 4, ISO 13485, ISO 14971, GDP and related regulations.
• Develop and approve controlled documents to ensure regulatory adherence.
• Provide quality guidance across design controls, risk management, V&V, packaging, and distribution.
• Identify gaps and collaborate with cross-functional teams to implement solutions.
• Drive continuous improvement of the QMS for combination products.

Skills

Quality Assurance

Medical devices

Regulatory knowledge

Education

BS/BA in chemistry/biology/biochemistry

Tools

Microsoft Office

SharePoint

DocuSign

Excel

QMS software

Job description

Arrowhead Pharmaceuticals, Inc. in Verona, WI seeks a Medical Device Quality Assurance lead who acts as SME for the QMS and owns the product complaint management process for clinical and commercial combination products.

You will ensure compliance with 21 CFR 820, ISO 13485, ISO 14971, and related regulations while guiding cross‑functional teams through design controls and lifecycle documentation. This full‑time onsite role reports to the Director, Supplier Quality and collaborates with Quality,