Specialist, Quality Systems & Compliance

MSD•North Wales, PA

2d•$87,300 - $137,400•Hybrid

About The Position

The Specialist, Quality Systems & Compliance in Device Regulatory & Quality supports the MDCP Complaints team and other DQ&R Systems tasks and priorities. The role interacts with cross-functional teams and sites, reviewing documentation for compliance with applicable Combination Product or Medical Device regulations and company requirements. The Specialist executes MDCP projects and supports the device data domain. The position reviews reportable external customer complaints and investigation reports, supports complaint investigations and risk management file updates, and helps ensure appropriate corrective and preventive actions. It also maintains MDCP data and access across company systems, coordinates SAP master-data updates, supports LMS training administration, maintains SharePoint sites and the MDCPQ mailbox, and maintains metrics and reporting for deviations, changes, CAPAs, and complaints.

Requirements

1–3 years of 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 a related technical field.
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 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.
Adaptability, complaints investigation, creative thinking, cross-functional teamwork, attention to detail, problem solving, and ability to work independently.

Nice To Haves

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

Responsibilities

Review reportable external customer complaints upon intake for appropriateness for health authority submission.
Document complaint database reviews and approvals.
Collaborate with the Site Complaint Investigating Unit and Device Technical Operations to ensure devices and components are considered in root cause analyses, including design considerations when manufacturing or packaging causes are not identified.
Collaborate with the Site Complaint Investigating Unit and Device to establish robust corrective and preventive actions addressing external customer complaints.
Review Device Risk Management Files to ensure investigated customer complaints are 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.
Assist with 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 the 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 associated with MDCP deviations, changes, CAPAs, and complaints.