Demo

Post Market Quality Specialist

LanceSoft
San Diego, CA Full Time
POSTED ON 3/3/2025
AVAILABLE BEFORE 5/25/2025

Post Market Quality Specialist

Pay $51 / hr based on experience

Job description :

Aligning and coordinating with Regional PMQ Representatives from EMEA, Latin America and Greater Asia to ensure alignment of field action execution.

Supporting timely MMS Field Action Committee (FAC) meetings.

Ensuring field action documentation (customer letter, 806 report, meeting minutes, file folder, etc.,) is created / maintained.

The jobholder ensures the timely execution of all process under their accountability and monitors performance against metrics to ensure compliance to all relevant global regulations and to ensure customer expectations are met. This should be achieved through outstanding communication, effective problem solving and active management of ambiguous situations. The jobholder must be well knowledgeable in FDA expectations, regulatory standards, and best practices in all areas for which they are accountable.

The jobholder will be part of the Central Post Market Quality organization. In this capacity, the jobholder will contribute to the overall growth and success of the Post Market Quality organization and participate or lead initiatives as opportunity arises and relates to MMS field action activities. As such, the jobholder needs to be able to operate across teams and align with Client's Values and Strong Teams Operating Model to support delivering the goals of the function efficiently and effectively.

RESPONSIBILITIES

Performs Global Regulatory Impact Assessment (GRIA) for North America and serves as coordinator to all other regions / countries for GRIA completion maintaining all regional documentation in the field action file

Assists in preparation of distribution reports as needed for field action preparation

Support MMS field action team in customer letter drafting, gathering stakeholder feedback, and finalization.

Maintains the "official record" field action file, ensuring all documentation is complete and appropriately filed in accordance with department standards to facilitate easy retrieval for audit support

Tracks recall activities to closure and prepares the final closure documentation for each field action file

Compiles field action data in support of MMS Management Reviews

Ensures all SharePoint data is complete for metric reporting

Provides documents in support of MMS audits as needed

Manages data requests from other departments for field action activities

Manages MMS related Canadian recall related activities within the NA PMQ organization, including customer letter creation, review and finalization.

Participates in post market surveillance data review meetings as needed in support of MMS field action activities

Serve as a team member and / or leader on projects for the department as assigned

Supports revisions to policies and procedures related to the MMS field action process as needed

Participates in the development, review, issuance and training of Client policies and procedures related to Post Market Quality

Develops solutions to routine assigned activities of moderate scope and complexity

This position has no direct reports and must accomplish tasks through cooperation with other Regulatory, Quality, Medical, Operations, and R&D professionals worldwide.

Ability to support business needs for Pacific Standard Time (PST).

QUALIFICATIONS :

BA or BS degree, with minimum of 1-2 years relevant experience in the medical device, in vitro diagnostics, or pharmaceutical industry.

Preferred Experience & Education :

Experience with post market surveillance and / or post market quality.

Expertise in participating in both internal and external audits.

Experience in 21CFR 806 and Canada Recall Regulations.

Experience with medical devices containing software.

Experience working within software management systems, such as, ERP and QMS systems.

Salary : $51

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