Specialist, Quality Systems & Compliance

Merck; New Jersey; On-site; USD 70,000 - 95,000; Full time

Job summary

Merck in New Jersey seeks a Specialist, Quality Systems & Compliance within Device Regulatory & Quality to support the MDCP Complaints team and related systems tasks. You will interact with cross-functional teams, review documentation for compliance, and drive root-cause and CAPA activities across SAP ECC, SAP PLM, and Veeva Vaults.

The role emphasizes independent work, team collaboration, and strong writing/review skills to ensure device and regulatory requirements are met in a fast-paced

Qualifications

• 1–3 years relevant experience in Regulatory CMC, Quality, development, testing or licensure of pharmaceutical products.
• Bachelor's degree in Science, Engineering, Health Care, STEM or related technical field.
• Ability to work in teams within a cross-functional framework and write/review technical documents.
• Strong written and verbal communication with detail-oriented project coordination.
• Experience coordinating regulatory data across ERP and quality systems is a plus.

Responsibilities

• Review reportable external customer complaints for health authority submission.
• Document review/approval in complaint database.
• Collaborate with Site Complaint Investigating Unit and Device TO for root cause analysis.
• Coordinate robust corrective/preventive actions for external complaints.
• Review Device Risk Management Files to ensure accurate representation of investigations.
• Maintain MDCP data across SAP ECC, SAP PLM, and Veeva Vaults.
• Manage SAP master data field ZZMAT_MDCP_ID and related updates.
• Support LMS training system stewardship and SharePoint maintenance.
• Monitor metrics and reporting for 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

Tools

SAP ECC

SAP PLM

Veeva Quality and Regulatory Vaults

Job description

Job Description

The Specialist, Quality Systems & Compliance in Device Regulatory & Quality, will be responsible for supporting MDCP Complaints team and other DQ&R Systems tasks and priorities as needed. This position will interact with cross-functional teams and sites. Activities will include review of documentation to ensure compliance with applicable Combination Product or Medical Device Regulations and internal of our company's requirements. In addition, the Specialist is responsible for execution of MDCP projects and support of the device data domain.

Primary activities include but are not limited to:

• 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

Education/Experience minimum requirement:

1-3 years relevant experience including Regulatory CMC, Quality, development, testing or licensure of pharmaceutical products; or related fields.

Required: Bachelor's degree in Science, Engineering, Health Care, STEM or related technical field

Required Skills:

Demonstrate the ability to work effectively in teams. Must be able to work independently within a cross functional framework and will involve detailed technical writing and review.

A high degree of creative thinking, resourcefulness, and networking will be required to coordinate projects or solve problems.

Must work independently and have excellent interpersonal relationship skills with flexibility to adapt to a fast-paced environment with changing priorities. Ability to work in a matrix organization and effective written and oral communicator.

Preferred experience and skills:

• Working knowledge of applicable medical device regulations (21CFR820, EU MDR, ISO 13485:2016), Risk Management Experience (ISO 14971:2012).
• Experience in Complaint Handling investigation process
• Understanding of Combination Product regulations (21 CFR Part 4 including Post Market Safety Reporting requirements).

#EligibleforERP

Required Skills:

Adaptability, Complaints Investigation, Creative Thinking, Cross-Functional Teamwork, Detail-Oriented, Problem Solving, Working Independently

US and Puerto Rico Residents Only:

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