Sr Mgr, QA/Quality Engineer, Device & Combination Products
Job in
Oklahoma City, Oklahoma County, Oklahoma, 73116, USA
Listed on 2026-10-09
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-09
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
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
- 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
- experience with ISO 13485-aligned systems, EU MDR, combination delivery systems, regulatory submissions, data integrity, electronic QMS, and lifecycle management of device records
fully remote within US; travel up to 25% domestically and internationally.
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