Specialist, Quality Systems & Compliance

MSD•Rahway, NJ

20h•Hybrid

About The Position

The Specialist, Quality Systems & Compliance works in Device Regulatory & Quality, supporting the MDCP Complaints team and other DQ&R Systems tasks and priorities. The role interacts with cross-functional teams and sites and reviews documentation for compliance with applicable combination product or medical device regulations and company requirements. It also executes MDCP projects and supports the device data domain. Key work includes reviewing reportable external customer complaints for health authority submission appropriateness, reviewing and approving complaint documentation and investigation reports, and collaborating with site complaint investigators and Device Technical Operations to ensure device components, design, root causes, risk-management files, and corrective or preventive actions are appropriately addressed. The role also supports MDCP data across company IT systems, including SAP ECC, SAP PLM, and Veeva Quality and Regulatory Vaults, and maintains related access, training, SharePoint, mailbox, metrics, and reporting activities. The role requires 1–3 years of relevant experience and a bachelor’s degree in a technical or related field. The position is based primarily in Rahway, New Jersey, with a hybrid work arrangement and 10% travel. It is a regular employee position; relocation and visa sponsorship are not available.

Requirements

Bachelor’s degree in Science, Engineering, Health Care, STEM, or a related technical field.
1–3 years of relevant experience in Regulatory CMC, Quality, development, manufacturing, testing, or licensure of pharmaceutical products, or related fields.
Ability to work effectively in teams and independently within a cross-functional framework.
Ability to perform detailed technical writing and review.
Creative thinking, resourcefulness, and networking skills to coordinate projects or solve problems.
Excellent interpersonal relationship skills and flexibility to adapt to a fast-paced environment with changing priorities.
Ability to work in a matrix organization.
Effective written and oral communication skills.

Nice To Haves

Working knowledge of applicable medical device regulations, including 21 CFR 820, EU MDR, and ISO 13485:2016.
Risk management experience, including ISO 14971:2012.
Experience with complaint-handling investigation processes.
Understanding of combination product regulations, including 21 CFR Part 4 and post-market safety reporting requirements.

Responsibilities

Review reportable external customer complaints upon intake to determine whether they are appropriate for health authority submission.
Review and approve documentation in the complaint database.
Collaborate with the Site Complaint Investigating Unit and Device Technical Operations to ensure the device and its components are adequately considered in root-cause analyses, including consideration of device design when manufacturing or packaging root causes are not identified.
Collaborate with the Site Complaint Investigating Unit and Device to ensure robust corrective and preventive actions address external customer complaints.
Review Device Risk Management Files to ensure the complaint under investigation is appropriately represented.
Collaborate with Device to update Device Risk Management Files as needed.
Review and approve reportable external customer complaint investigation reports before submission to health authorities.
Support maintenance of MDCP data across company IT systems, including SAP ECC, SAP PLM, and Veeva Quality and Regulatory Vaults.
Coordinate and approve, in the Quality role, creations and changes to SAP master data field ZZMAT_MDCP_ID.
Submit SAP post-approval updates to the GCM TW team to complete corresponding MDCP identifier updates.
Maintain SAP access and role mapping for the Device Quality & Regulatory Complaints team.
Support the team as an LMS training system steward.
Maintain team SharePoint sites.
Maintain the MDCPQ mailbox and associated activities.
Maintain metrics and reporting for MDCP deviations, changes, CAPAs, and complaints.
Support the MDCP Complaints team and other DQ&R Systems tasks and priorities as needed.