Sr Mgr, QA/Quality Engineer, Device & Combination Products

Scorpion Therapeutics; United States; Remote; USD 140,000 - 210,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Manager/Quality Engineer to lead QA/QE for device and combination products, ensuring compliance, quality, and regulatory readiness of drug substance, drug product, and device components in a remote setup.

You will provide technical leadership to internal teams and external suppliers, review manufacturing data, and oversee regulatory activities including GxP audits, CAPAs, and change controls.

Qualifications

• Bachelor's degree in Chemistry, Biology, Engineering, or related.
• 8+ years in Quality Assurance/Engineering within medical devices or drug-device combination products.
• Experience with GxP, regulatory audits, and managing CDMOs.

Responsibilities

• Provide technical leadership to external suppliers and internal teams.
• Review and approve manufacturing and stability data.
• Oversee regulatory compliance (21 CFR Parts 4, 210/211, ISO 13485, ISO 14971).
• Support supplier qualification, audits, and inspections.
• Lead investigations, CAPAs, change controls, and risk assessments.
• Collaborate on cross-functional projects supporting development and commercial supply.

Skills

Quality Assurance

Quality Engineering

Regulatory compliance

GxP

Audits

CAPA

Change control

Risk assessment

CDMO management

Regulatory submissions

Lifecycle management

Education

Bachelor's in Chemistry, Biology, Engineering, or related

Tools

Electronic QMS

Job description

Role: Senior Manager/Quality Engineer leading QA/QE for device and combination products, ensuring compliance, quality, and regulatory readiness of drug substance, drug product, and device components in a remote setting.

Responsibilities

• provide technical leadership to external suppliers and internal teams
• review and approve manufacturing and stability data
• oversee regulatory compliance (21 CFR Parts 4, 210/211, ISO 13485, ISO 14971)
• support supplier qualification, audits, and inspections
• lead investigations, CAPAs, change controls, and risk assessments
• collaborate on cross-functional projects supporting development and commercial supply

Qualifications

• Bachelor's in Chemistry, Biology, Engineering, or related
• 8+ years in Quality Assurance/Engineering within medical devices or drug-device combination products
• experience with GxP, regulatory audits, and managing CDMOs
• strong knowledge of cGMPs, ISO standards, and combination product regulations

Preferred

• experience with ISO 13485-aligned systems, EU MDR, combination delivery systems, regulatory submissions, data integrity, electronic QMS, and lifecycle management of device records

Work setup

fully remote within US; travel up to 25% domestically and internationally.