Product Compliance Specialist

Regulatory/Compliance | Santa Ana, CA

Job Function:

We are hiring a Product Compliance Specialist. The Compliance Specialist will perform, execute and manage, Quality System compliance tasks related to Complaints, CAPA, Quality Planning, and Facility Change Requests (FCRs). The person in this role will also manage the customer complaint process, including but not limited to, complaint intake, documentation and investigation, customer follow-up, tracking and trending. The Compliance Specialist will also lead and manage complaints investigations internally and communicate directly with customers. In addition, this person will lead and manage CAPA investigations, Quality Planning and FCRs. This position receives and processes customer inquiries and complaints and will document and convey this information to the appropriate functional department for resolution. In addition, the Compliance Specialist will lead the activities related to resolving complaints, assessing corrective action, and corrective action preventive action (CAPA). This person will also help to manage Quality System compliance activities, such as overseeing the CAPA program by coordinating with individual CAPA owners, manage and perform Quality Planning and FCR activities.

Job Duties:

  • Manage and perform product Compliance activities, including, but not limited to, the following:
    • CAPA initiation, closure and investigation support of assigned CAPA owners
    • Review and planning for Facility Change Requests (FCR)
    • Writing, review and closure of Quality Planning Activities among all sites
    • Compliant documentation intake, investigation oversight, customer follow-up, tracking and trending
  • Determine the nature of direct and indirect customer inquiries, and classify them for resolution
  • Manage and monitor customer inquiries associated with complaints or CAPAs
  • Manage and coordinate cross-functional activities for Compliance activities
  • Ensure timely and accurate closure of customer complaints, CAPAs, FCRs and Quality Planning activities and that established turnaround times are met
  • Ensure compliance of processes and procedures to applicable standards related to Compliance activities, including but not limited to, complaints, CAPAs, FCRs and Quality Planning                     
  • Assist in the communication with regulatory agencies, notified body, an

Experience/Education:

  • BS or BA in a scientific discipline preferred
  • Two (2) or more years of experience in Quality Assurance/Regulatory Affairs/Compliance, technical and customer support in a medical device discipline
  • Knowledge and understanding of GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, ISO harmonized standards (EN14971, EN 13408, EN 13824)
  • Knowledge and understanding of quality control methodology, QA control systems and production methodologies
  • Experience in cell and tissues culture; Experience can be from education or industry
  • Ability to obtain cooperation from other groups and lead cross functional teams
  • Experience with risk management and Failure Mode Effects Analysis (FMEA)
  • Strong root cause analysis skills required
  • Proficient in Microsoft Word, Excel, PowerPoint, Outlook

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Principals only. No recruiters please.

FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

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