Sr. Specialist, Post Market Quality - Onsite (Urgent Need)

Position : Sr. Specialist, Post Market Quality

Location : San Diego, CA

Duration : 12 Months

Total Hours/week : 40.00

1st Shift

Client : Medical Devices Company

Job Category : Engineering/Technical

Level of Experience : Mid-Level

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

Description:

• The Sr. Specialist, Post Market Quality position reports directly to the Director, Post Market Quality, Field Action.
• The Sr. Specialist, Post Market Quality position is responsible for working with Medical Management Solutions (MMS) on various post market quality issues, including, Supporting timely execution of field actions within North America for MMS related field actions.
• 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 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 BD 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.