Quality Systems & Compliance Specialist - Medical Devices

Merck & Co.; North Wales (Montgomery County); Hybrid; USD 87,000 - 137,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan

Paid holidays and vacation

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a Specialist, Quality Systems & Compliance in Device Regulatory & Quality to support MDCP Complaints and related systems, collaborating across sites to ensure compliance with 21 CFR, EU MDR, ISO 13485 and internal requirements.

The role includes reviewing complaints, maintaining SAP master data, supporting CAPAs, and ensuring robust corrective actions, with opportunities for annual bonus and long-term incentives in a hybrid work environment.

Qualifications

• 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

Responsibilities

• Review reportable external customer complaints, upon intake, for appropriateness for health authority submission.
• Document review/approval in complaint database
• Collaborate with the Site Complaint Investigating Unit and Device -Technical Operations (TO) to ensure the device and device components are adequately considered as part of the root cause analysis and to ensure the design of the device and device components are adequately considered when manufacturing or packaging root causes are not identified.
• Collaborate with Site Complaint Investigating Unit and Device to ensure robust corrective and/or preventive actions are put in place to address external customer complaints
• Review the Device Risk Management Files to ensure the customer complaint being investigated is appropriately represented
• Collaborate with Device to update the Device Risk Management files, as needed.
• Review and approve reportable external customer complaint investigation reports prior to their submission to health authority
• Assist with maintenance of MDCP data across our company's IT systems, including but not limited to SAP ECC, SAP PLM, and Veeva Quality and Regulatory Vaults
• Coordinates, approves as Quality role all creations and changes to SAP master data field ZZMAT_MDCP_ID
• Submits SAP post-approval updates to GCM TW team to complete the same MDCP identifier updates GCM updates
• Maintains SAP access and role mapping for Device Quality & Regulatory Complaints team
• Supports team as LMS training system steward
• Maintains team SharePoint sites
• Maintains MDCPQ mailbox and associated activities
• Maintains metrics and reporting associated with 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 Vaults

Job description

Merck & Co., Inc. in Rahway, NJ seeks a Specialist, Quality Systems & Compliance in Device Regulatory & Quality to support MDCP Complaints and related systems, collaborating across sites to ensure compliance with 21 CFR, EU MDR, ISO 13485 and internal requirements.

The role includes reviewing complaints, maintaining SAP master data, supporting CAPAs, and ensuring robust corrective actions, with opportunities for annual bonus and long-term incentives in a hybrid work environment.