Quality Systems & Compliance Specialist — Hybrid

Merck; West Point (PA); Híbrido; USD 90.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work

Descripción de la vacante

Merck is seeking a Specialist, Quality Systems & Compliance in Device Regulatory & Quality to support the MDCP Complaints team and related systems. You will engage cross-functionally to ensure compliance with medical device regulations and internal requirements, while executing MDCP projects and supporting device data across SAP and Veeva Vaults.

The role emphasizes review of complaints, data maintenance, and collaboration with QA, TO, and device teams to drive corrective actions and risk

Formación

• 1-3 years relevant experience including Regulatory CMC, Quality, development, manufacturing, testing or licensure of pharmaceutical products; or related fields.
• Bachelor’s degree in Science, Engineering, Health Care, STEM or related technical field
• Ability to work in a cross-functional environment and produce detailed technical writing

Responsabilidades

• Review reportable external customer complaints, upon intake, for appropriateness for health authority submission
• Document review/approval in complaint database
• Collaborate with Site Complaint Investigating Unit and Device-Technical Operations to ensure root cause analysis considers device design and manufacturing factors
• Collaborate with Site Complaint Investigating Unit and Device to ensure robust corrective and preventive actions are implemented
• Review the Device Risk Management Files to ensure the customer complaint is accurately represented
• Collaborate with Device to update the Device Risk Management files, as needed
• Review and approve reportable external customer complaint investigation reports prior to submission to health authority
• Assist with maintenance of MDCP data across SAP ECC, SAP PLM, and Veeva Quality/R&V Vaults
• Coordinate, approve as Quality role all creations/changes to SAP master data field ZZMAT_MDCP_ID
• Submit SAP post-approval updates to GCM TW team for MDCP identifier updates
• Maintain SAP access and role mapping for Device Quality & Regulatory Complaints team
• Support LMS training system as steward
• Maintain team SharePoint sites
• Maintain MDCPQ mailbox and related activities
• Maintain metrics and reporting for MDCP deviations, changes, CAPAs and complaints

Conocimientos

Adaptability

Teamwork

Problem Solving

Detail-oriented

Educación

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

Herramientas

SAP ECC

SAP PLM

Veeva Vaults

Descripción del empleo

Merck is seeking a Specialist, Quality Systems & Compliance in Device Regulatory & Quality to support the MDCP Complaints team and related systems. You will engage cross-functionally to ensure compliance with medical device regulations and internal requirements, while executing MDCP projects and supporting device data across SAP and Veeva Vaults.

The role emphasizes review of complaints, data maintenance, and collaboration with QA, TO, and device teams to drive corrective actions and risk