After Market Surveillance Coordinator

Website Berman Larson Kane

Best Technical Staffing Since 1980

After Market Surveillance Coordinator

Summary: The Post Market Surveillance Coordinator plays a pivotal role in SNA’s compliance with quality system regulations. They lead the Complaints, CAPA, Vigilance (MDR/MPR), and Recall processes for SNA. Post Market Surveillance Coordinator is an SME and back room leader during third party audits. They work closely with the Hotline, ASA, and HQ Q&C and is SNA’s primary interface with FDA and Health Canada when complaints require reporting.

Essential Duties & Responsibilities:

Acts as key point person for SNA Quality & Compliance in the areas of complaints evaluation and documentation, CAPA Board chairperson, MDR/MPR Reporting, and Recall execution (within North America).

Assures that all US MDRs and Canadian MDPRs are reported in an accurate and timely way.

Acts as the Subject Matter Expert for and owns SOPs and Forms for the above processes.

Assists all departments with corrections and corrective actions as required. Assures timely completion of CAPAs/IMS events. Is a resource to others for Quality Events (preventive actions).

Supports the Quality & Compliance team during External Audits/Inspections as needed (e.g. front room SME and backroom leader). Applies knowledge of SNA systems to assure accurate and timely retrieval of quality records and documents upon request.

Performs other quality management duties as required.

Responsible for the consistent compliant execution of the complaints evaluation process. This includes data gathering and evaluation and partnering with Hotline and ASA.

Responsible for making systematic enhancements to the complaints, CAPA, and recall processes to optimize the flow of and documentation of key information.

Assists the Director, Quality & Compliance with tracking and trending metrics needed for the Management Review Process.

Participates in the internal audit process as an Internal Auditor and/or Flash Inspector. Maintains all associated training credentials.

Education & Requirements:

Bachelor’s degree in Engineering, Science, or related field required (Master’s degree preferred).

Five years’ experience in medical device quality or quality systems required (or Master’s degree + 4 Years’ experience.)

High level of knowledge in medical device and FDA Regulations is required. Prior experience with medical device complaint reporting a plus. ISO experience is preferred.

ASQ or similar professional certifications are a plus (e.g. CMQ/OE, CQA, CQE).

Up to 10% travel required.

Skills:

Proficiency in MS Office (especially Word, Excel, Project, and Powerpoint).

Demonstrated ability to solve complex challenges with data analysis.

Ability to learn new applications quickly.

Planning, organization, problem solving, communication, analytical skills.

Ability to present data in effective ways for presentations to management.

Ability to communicate with all levels of the organization.

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