Post Market Quality Specialist

A-Line is now hiring a Senior Post Market Quality Specialist in San Diego, CA The Sr. Specialist, Post Market Quality position reports directly to the Director, Post Market Quality, Field Action. This role is responsible for working with Medical Management Solutions (MMS) on various post-market quality issues, ensuring the timely execution of field actions within North America for MMS-related field actions. This position will align and coordinate with Regional PMQ Representatives from EMEA, Latin America, and Greater Asia to ensure field action execution alignment and support MMS Field Action Committee (FAC) meetings. The Sr. Specialist will also be responsible for maintaining field action documentation, including customer letters, 806 reports, meeting minutes, and file folders. The jobholder ensures compliance with all relevant global regulations, customer expectations, and company standards. This is achieved through excellent communication, effective problem-solving, and proactive management of ambiguous situations. The ideal candidate must have strong knowledge of FDA expectations, regulatory standards, and best practices in post-market quality. Position: Sr. Specialist, Post Market Quality Location: Hybrid (4 days on-site) San Diego, CA Bill Rate: $42/hr Experience: 1-2 years Benefits: Full benefits after 90 days of employments – dental, vision, and health As well as a company 401(k) matching program after 1 year of employment on date of eligibility. Responsibilities Perform Global Regulatory Impact Assessment (GRIA) for North America and coordinate GRIA completion with other regions/countries. Maintain regional documentation in the field action file. Assist in the preparation of distribution reports for field action preparation. Support MMS field action team in drafting customer letters, gathering stakeholder feedback, and finalizing documents. Maintain official records of field action files, ensuring completeness and compliance with department standards. Track recall activities to closure and prepare final closure documentation for field action files. Compile field action data to support MMS Management Reviews. Ensure SharePoint data is complete for metric reporting. Provide documents in support of MMS audits as needed. Manage data requests from other departments related to field action activities. Oversee MMS-related Canadian recall activities within the NA PMQ organization, including customer letter creation, review, and finalization. Participate in post-market surveillance data review meetings in support of MMS field action activities. Serve as a team member or leader on department projects as assigned. Support revisions to policies and procedures related to the MMS field action process. Participate in the development, review, issuance, and training of BD policies and procedures related to Post Market Quality. Develop solutions for routine assigned activities of moderate scope and complexity. Work collaboratively across Regulatory, Quality, Medical, Operations, and R&D teams worldwide. Ability to support business needs in the Pacific Standard Time (PST) zone. Qualifications Education: BA or BS degree. Experience: Minimum of 1-2 years of relevant experience in the medical device, in vitro diagnostics, or pharmaceutical industry. Preferred Experience & Skills Experience with post-market surveillance and/or post-market quality. Expertise in participating in internal and external audits. Knowledge of 21CFR 806 and Canadian Recall Regulations. Experience with medical devices containing software. Experience working within software management systems such as ERP and QMS systems. This is an excellent opportunity for a detail-oriented professional to contribute to a dynamic and mission-driven team, ensuring high-quality standards and compliance in the post-market quality sector. To Apply: Email your resume to Hforetalinestaffing.com or apply directly to this posting

Location: San Diego, CA, US

Posted Date: 2/5/2025