Device Quality & Regulatory Compliance Specialist

Merck & Co.; West Point (PA); Ibrido; USD 87.000 - 137.000; Tempo pieno

Descrizione del lavoro

Merck & Co. seeks a Specialist for Quality Systems & Compliance within Device Regulatory & Quality to support the MDCP complaints team and cross-functional MDSQ processes. You will review documentation for compliance, manage complaint records, and collaborate with site teams to ensure robust CAPAs and risk management updates.

This role involves maintaining data across SAP and Veeva vaults. The position emphasizes independent working within a matrix environment and requires a Bachelor’s degree in

Competenze

• 1-3 years relevant experience including Regulatory CMC, Quality, development, manufacturing, testing or licensure of pharmaceutical products; or related fields.
• Required: Bachelor's degree in Science, Engineering, Health Care, STEM or related technical field

Mansioni

• Review reportable external customer complaints for health authority submission
• Document review/approval in complaint database
• Collaborate with Site Complaint Investigating Unit and Device-Technical Operations to ensure proper root cause analysis
• Assist with robust corrective and preventive actions to address external customer complaints
• Review Device Risk Management Files to ensure customer complaint representation
• Update Device Risk Management files as needed
• Approve reportable external customer complaint investigation reports prior to health authority submission
• Maintain MDCP data across SAP ECC, SAP PLM, and Veeva systems
• Manage SAP master data field ZZMAT_MDCP_ID changes and updates
• Submit SAP post-approval updates to GCM TW team for MDCP identifier updates
• Maintain SAP access and role mapping for Device Quality & Regulatory Complaints
• Support LMS training system stewardship
• Maintain SharePoint sites and MDCPQ mailbox
• Maintain metrics for MDCP deviations, changes, CAPAs, and complaints

Conoscenze

Regulatory knowledge

Quality systems

Cross-functional teamwork

Technical writing

Independent working

Formazione

Bachelor's degree in Science/Engineering/Health Care/STEM

Strumenti

SAP ECC

SAP PLM

Veeva Vaults

Descrizione del lavoro

Merck & Co. seeks a Specialist for Quality Systems & Compliance within Device Regulatory & Quality to support the MDCP complaints team and cross-functional MDSQ processes. You will review documentation for compliance, manage complaint records, and collaborate with site teams to ensure robust CAPAs and risk management updates.

This role involves maintaining data across SAP and Veeva vaults. The position emphasizes independent working within a matrix environment and requires a Bachelor’s degree in