Hybrid Quality Systems & Compliance Specialist

Merck; North Wales (Montgomery County); Hybrid; USD 65,000 - 85,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Merck & Co., Inc. in the United States seeks a Specialist for Quality Systems & Compliance in Device Regulatory & Quality to support MDCP Complaints and related systems. You will review complaints, manage data in SAP and Veeva Vaults, and coordinate corrective actions with cross-functional teams.

The role requires 1–3 years of relevant experience, a science/engineering degree, and the ability to work in a hybrid environment across locations. Strong writing and collaborative skills are essential.

Qualifications

• Must work well in a team and communicate effectively.
• Demonstrates creativity, resourcefulness and project coordination.
• Ability to work independently in a matrix organization with changing priorities.

Responsibilities

• Review reportable external customer complaints for health authority submission.
• Document review/approval in the complaint database.
• Collaborate with Site Complaint Investigating Unit and Device TO on root cause analysis.
• Ensure robust corrective/preventive actions for external complaints.
• Review Device Risk Management Files for accurate representation.
• Update MDCP data across SAP ECC/PLM and Veeva Vaults.
• Approve reportable complaint investigation reports before health authority submission.
• Maintain SAP master data ZZMAT_MDCP_ID and related mappings.
• Support LMS training system stewardship and SharePoint sites.
• Track MDCP deviations, changes, CAPAs and complaints.

Skills

Adaptability

Complaints Investigation

Creative Thinking

Cross-Functional Teamwork

Detail-Oriented

Problem Solving

Working Independently

Education

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

Tools

SAP ECC

SAP PLM

Veeva Quality and Regulatory Vaults

SharePoint

Job description

Merck & Co., Inc. in the United States seeks a Specialist for Quality Systems & Compliance in Device Regulatory & Quality to support MDCP Complaints and related systems. You will review complaints, manage data in SAP and Veeva Vaults, and coordinate corrective actions with cross-functional teams.

The role requires 1–3 years of relevant experience, a science/engineering degree, and the ability to work in a hybrid environment across locations. Strong writing and collaborative skills are essential.