Product Complaint Specialist II

MESO SCALE DIAGNOSTICS, LLC.•Gaithersburg, MD

13h•$78,100 - $116,200•Onsite

About The Position

The Product Complaint Specialist 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. This role is also responsible for the management of the Field Action process from initial assessment through closure.

Requirements

Bachelor’s degree in Biology, Chemistry, Biochemistry or other Life Sciences or Engineering is required.
Minimum of 4 years of experience in biotechnology, medical devices, in vitro diagnostics, pharmaceuticals or related industry required.
Working knowledge of ISO 9001, or ISO 13485 strongly preferred.
Familiarity with Salesforce or similar electronic complaint management systems preferred.
Strong understanding of quality principles, analytical problem solving, and root cause methodologies (e.g., 5Whys, Fishbone, FMEA).
Excellent 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 (e.g., Salesforce, SharePoint, QMS platforms).
Strong interpersonal skills with the ability to collaborate effectively across departments and functional areas.
High attention to detail, accuracy, and adherence to compliance requirements.

Nice To Haves

Education requirements may be substituted by previous experience in customer complaint handling and CAPA management.
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) is preferred.

Responsibilities

Review complaint records for completeness and accuracy prior to closure and collaborate with internal teams to collect any missing required information.
Review 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 and recommend the need for Field Actions.
Manage Field Actions from initiation to closure, including drafting customer notifications, routing documentation for approvals, and executing notification campaigns.
Generate, analyze, and report quality metrics to assess QMS performance and identify opportunities for improvement.
Serve as a Quality representative in cross-functional meetings; provide guidance, clarification, and coaching to stakeholders on quality principles and QMS expectations.
Review and approve documentation (e.g., procedures, reports, assessments)
Support external regulatory audits, certification audits, and customer audits by providing documentation, records, and subject-matter expertise.
Promote compliance and continual improvement of QMS processes and procedures across the organization.
Assist during internal and external audits of the complaint-handling program.
Other duties as assigned.