MDCP Quality Systems & Complaints Specialist

MSD; Rahway (NJ); Ibrido; GBP 65.000 - 103.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid holidays

Vacation days

Sick days

Descrizione del lavoro

Merck in Rahway, NJ seeks a Specialist, Quality Systems & Compliance to support the MDCP Complaints team and DQ&R systems tasks. You will review documentation for regulatory compliance, coordinate cross-functional activities, and support device data domain projects.

The role requires collaboration with Site Complaint Investigating Unit and Device teams, plus maintenance of SAP/IT systems and device risk files. Hybrid work arrangement is available.

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 eligibility.
• Document review/approval in complaint database.
• Collaborate with Site Complaint Investigating Unit and Device-Technical Operations on root cause analysis and device design considerations.
• Support robust corrective and preventive actions for external customer complaints.
• Review and update Device Risk Management Files to reflect investigations.
• Approve reportable external customer complaint investigation reports prior to health authority submission.
• Assist with maintenance of MDCP data across SAP ECC, SAP PLM, and Veeva Vaults.

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

Strumenti

SAP ECC

SAP PLM

Veeva Quality & Regulatory Vaults

Descrizione del lavoro

Merck in Rahway, NJ seeks a Specialist, Quality Systems & Compliance to support the MDCP Complaints team and DQ&R systems tasks. You will review documentation for regulatory compliance, coordinate cross-functional activities, and support device data domain projects.

The role requires collaboration with Site Complaint Investigating Unit and Device teams, plus maintenance of SAP/IT systems and device risk files. Hybrid work arrangement is available.