Device Quality Systems & Compliance Specialist

Regulatory Jobs; Rahway (NJ); Ibrido; USD 87.000 - 137.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays and vacation

Sick days and other leave

Descrizione del lavoro

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

This role supports the MDCP Complaints team and a variety of MDCP data tasks, engaging cross-functional teams to ensure compliance with regulatory requirements for medical devices and combination products. You will review complaints, manage documentation, and contribute to CAPAs, risk management, and data integrity across SAP and Veeva systems, while maintaining

Competenze

• Bachelor’s degree in a science/engineering/healthcare/STEM field is required.
• 1–3 years of relevant experience in regulatory/quality roles or related fields.
• Strong technical writing, communication, and cross-functional collaboration skills.

Mansioni

• Review reportable external customer complaints for health authority submission suitability.
• Document review and approval in the complaint database.
• Collaborate with Site Complaint Investigating Unit and Device-Technical Operations to consider root causes for design and manufacturing issues.
• Support robust corrective and preventive actions addressing external complaints.
• Review Device Risk Management Files to ensure accurate representation of investigations.
• Update Device Risk Management files as needed and maintain MDCP data across IT systems (SAP ECC, SAP PLM, Veeva Vaults).
• Coordinate, approve as Quality role, all changes to SAP master data field ZZMAT_MDCP_ID.
• Submit SAP post-approval updates to GCM TW team to complete MDCP identifier updates.

Conoscenze

Adaptability

Complaints Investigation

Creative Thinking

Cross-Functional Teamwork

Detail-Oriented

Problem Solving

Working Independently

Formazione

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

Descrizione del lavoro

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

This role supports the MDCP Complaints team and a variety of MDCP data tasks, engaging cross-functional teams to ensure compliance with regulatory requirements for medical devices and combination products. You will review complaints, manage documentation, and contribute to CAPAs, risk management, and data integrity across SAP and Veeva systems, while maintaining