OVERVIEW :

Our client, a US Fortune 250 company and a global medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished Post Market Quality Specialist – Medical Devices.

** JOB TITLE: Post Market Quality Specialist – Medical Devices

** LOCATION: Hybrid Role | 10020 Pacific Mesa Blvd San Diego CA 92121

** DURATION: 12 months +

Pay Rate: $45.00/hr. W2 - $50.00/hr. W2 (depending upon experience)

JOB RESPONSIBILITIES:

• 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’s Values and Strong Teams Operating Model to support delivering the goals of the function efficiently and effectively.
• 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 preparationSupport 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 activitiesServe 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 neededParticipates 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)

JOB REQUIREMENT:

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

I'd love to talk to you if you think this position is right up your alley, and assure a prompt communication, whichever direction. If you are looking for rewarding employment and a company that puts its employees first, we'd like to work with you.

Recruiter Name: Lalit Malgotra

Title: Lead Recruiter

Email ID:

Company Overview:

Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally: as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with a service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients’ businesses forward.

Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Applicants with criminal histories are considered in a manner that is consistent with local, state and federal laws.