Product Compliance Specialist

Product Compliance | Santa Ana, CA

Job Description:

We are hiring a Product Compliance Specialist. The Product Compliance Specialist will perform, execute, and manage Quality System product compliance tasks related to complaints, CAPA, quality planning, and Facility Change Requests (FCRs). This position receives and processes customer inquiries and complaints and will document and convey this information to the appropriate functional department for resolution. The Product Compliance Specialist will lead the activities related to resolving complaints, assessing corrective action, and corrective action preventive action (CAPA).

Responsibilities:

  • 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
    • Complaint documentation intake, investigation oversight, customer follow-up, tracking and trending
  • Determine the nature of direct and indirect customer inquiries, and classify them for resolution.
  • Managing and monitoring customer inquiries associated with complaints or CAPAs. Managing and coordinating cross-functional activities for Compliance activities.
  • Ensuring timely and accurate closure of customer complaints, CAPAs, FCRs and Quality Planning activities and that established turnaround times are met.
  • Ensuring compliance of processes and procedures to applicable standards related to Compliance activities, including but not limited to, complaints, CAPAs, FCRs and Quality Planning.
  • Assisting in the communication with regulatory agencies, notified body, and competent authorities as associated with Compliance activities. Other duties as assigned.

Experience/Education:

  • BS. or B.A. in 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.
  • GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, ISO harmonized
  • standards (EN14971, EN 13408, EN 13824).
  • 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.
  • Ability to speak, write, and read English.
  • Good oral and written communication skills.

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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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