Quality Systems & Compliance Specialist (MDCP & Complaints)

Merck & Co.; Upper Gwynedd Township (Montgomery County); Hybride; USD 87 000 - 137 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Long-term incentive

Comprehensive benefits

Résumé du poste

Merck & Co., Inc. in Rahway, NJ, seeks a Specialist for Quality Systems & Compliance within Device Regulatory & Quality.

You will support the MDCP Complaints team and cross-functional groups, reviewing documentation for compliance with device regulations and internal requirements. Responsibilities include handling external customer complaint reviews, action tracking, and data maintenance across SAP, PLM, and Veeva Vaults, with emphasis on risk management and CAPA activities.

Qualifications

• 1-3 years of relevant experience in Regulatory CMC, Quality, development, manufacturing or related fields.
• Bachelor's degree in Science, Engineering, Health Care, STEM or related technical field required.

Responsabilités

• Review reportable external customer complaints for health authority submission readiness.
• Document review and approval in complaint database.
• Collaborate with Site Complaint Investigating Unit to ensure RCAs consider device design and packaging impacts.
• Support robust corrective and preventive actions for external complaints.
• Review Device Risk Management Files to ensure accurate representation of investigations.
• Maintain MDCP data across SAP, PLM, and Veeva systems; manage SAP master data (ZZMAT_MDCP_ID).
• Submit SAP post-approval updates and maintain SAP access/role mapping.
• Act as LMS system steward and maintain team SharePoint sites.
• Generate metrics and reporting for MDCP deviations, changes, CAPAs and complaints.

Connaissances

Adaptability

Complaints Investigation

Creative Thinking

Cross-Functional Teamwork

Detail-Oriented

Problem Solving

Independent Working

Formation

Bachelor's degree in Science, Engineering, Health Care, STEM or related technical field

Outils

SAP ECC

SAP PLM

Veeva Quality & Regulatory Vaults

Description du poste

Merck & Co., Inc. in Rahway, NJ, seeks a Specialist for Quality Systems & Compliance within Device Regulatory & Quality.

You will support the MDCP Complaints team and cross-functional groups, reviewing documentation for compliance with device regulations and internal requirements. Responsibilities include handling external customer complaint reviews, action tracking, and data maintenance across SAP, PLM, and Veeva Vaults, with emphasis on risk management and CAPA activities.