Product Complaint Specialist I

MESO SCALE DIAGNOSTICS, LLC.•Gaithersburg, MD

12h•Onsite

About The Position

The Product Complaint Specialist I is responsible for ensuring all customer complaints and feedback for products and services are adequately documented and managed in accordance with internal procedures, ISO 9001 and 13485 standards, and applicable regulatory requirements.

Requirements

Bachelor’s degree in Biology, Chemistry, Biochemistry or other Life Sciences or Engineering discipline required.
Equivalent combination of education and relevant experience considered.

Nice To Haves

One to two years of experience in biotechnology, medical devices, in vitro diagnostics, pharmaceuticals, or related industry preferred.
Previous experience developing metrics, analyzing data and generating reports preferred.
Previous experience supporting recalls, corrections, or field actions preferred.
ASQ Certification (e.g., CQE, CRE, CQA) preferred.
Working knowledge of ISO 9001 or ISO 13485 strongly preferred.
Understanding of quality principles, analytical problem solving, and root cause analysis methodologies preferred.
Solid verbal and written communication skills; able to translate complex technical issues into clear, concise summaries for stakeholders and management.
Ability to manage multiple priorities in a fast-paced, dynamic environment while meeting established timelines.
Proficiency in Microsoft Office Suite; ability to quickly learn new software tools.
Solid interpersonal skills with the ability to collaborate effectively across departments and functional areas.
High attention to detail, accuracy, and adherence to compliance requirements.

Responsibilities

Assist in reviewing complaint records for completeness and accuracy prior to closure and collaborate with internal teams to ensure all required information is collected.
Assist in reviewing complaint investigations, including root cause analysis, for adequacy.
Collaborate with cross-functional teams to drive timely completion of investigations and related activities.
Assess the need for Corrective and Preventive Actions (CAPA) as a result of complaints.
Participate in Material Review Board meetings to review and approve product dispositions.
Generate, analyze, and report quality metrics to assess Quality Management System (QMS) performance and identify opportunities for improvement.
Assist with quality-related documentation (e.g., procedures, reports, assessments) related to complaint case management processes.
Assist during internal and external audits of the complaint-handling program by providing documentation and records, as needed.
Promote compliance and continual improvement of QMS processes and procedures across the organization.
Other duties as assigned.