Join Our Mailing List Today!

NOTICE: Online ordering will be disabled 1/27-2/3. Learn More.

Sr Mgr of Tech Investigation

Regulatory / Compliance | Santa Ana, CA

Job Description:

This role will lead technical support process from services, including, but not limited to addressing customer’s inquiries, leading technical resolution to challenges in the field, assisting with and performing product investigations, including full CAPA process, as applicable, for all business lines. Responsible for directly leading, Technical Investigations Team; as well as indirect engagement and alignment the Field Technical Applications Specialist (TAS), Field Application Scientists (FAS), Medical Business Unit Clinical Coordinator, Sales and Territory Managers and Managers of Customer Service. Oversee collection, documentation, and management all customer complaints and inquiries to ultimate resolution and communication with customers, sales, marketing, customer service and applicable internal teams. Engage and ensure appropriate product compliance in line with SOPs and RA/QA requirements, which includes tasks related to Complaints, CAPA, Quality Planning, and Facility Change Requests (FCRs). Manage customer complaint process, including but not limited to, complaint intake, documentation and lead of investigations, customer follow-up and management, and tracking, trending and reporting of Complaint Program management and activities. Lead and manage complaints investigations with support from cross-functional teams, and communicate directly with customers. Responsible for CAPA program management and oversight, including but not limited to initiation, assist CAPA owner with investigation, root cause analysis, write-up, implementation of corrections, monitoring for verification and tracking, trending and reporting of CAPA program. Lead and manage company Quality Planning and FCRs from a product compliance perspective. Lead and manage all levels of Technical Investigators to ensure all duties of the department are handled.


  • Lead, manage and mentor Technical Service Investigator team.
  • Advise in real time, product technical matters for effective, accurate situational awareness and rapid escalation of issues as needed.
  • Utilizing the resources within the company, ensure quick resolution and documentation of customer inquiries. This includes providing timely and accurate solutions to customers' technical challenges, troubleshooting issues, and addressing any concerns raised by customers. Work collaboratively with internal teams, such as customer support, sales, FAS and R&D, to offer efficient and effective resolutions to customer inquiries. Moreover, the company's reputation as a technical resource and industry leader must be maintained, by playing a key role in building and fostering this recognition among customers.
  • Efficiently address formulation disclosure requests, by carefully evaluating the requirements of both customers and the company, and suggesting viable solutions that meet the interests of all stakeholders. Coordinate and organize Technical Application Specialists and Field Application Scientists to address technical issues with products or services and improved evaluation outcomes at customer sites. In addition, regularly conduct surveys and gather feedback from both sales representatives and customers to gather insights on the product's performance and usage. This feedback can help identify areas for improvement and inform future product development and sales strategies.
  • Manage and drive continuous improvement for metrics for productivity, customer satisfaction and overall customer engagement.
  • In collaboration with other departments and managers, develop and maintain a priority list of technical improvement initiatives across the company gain agreement on resolution, resources and timing.
  • Revise or create Technical Support SOPs based on feedback and data.
  • Coordinate internal resources and cross-functional teams to implement solutions to product issues or positioning, ensuring that timelines are met and customer satisfaction is achieved..
  • Develop and deliver relevant training to enable widespread adoption of technical information and methodologies for commercial and support organizations. EV: not clear what the requirement is.
  • Develop and oversee key performance indicators (e.g. SCARs, evaluations, etc.) to ensure improvement.  Create measurement of indicators to track progress.
  • Assess and evaluate training needs of direct reports; ensure training and development needs are met within department plans and budgets.  This training requirement may apply to other department personnel.
  • Ensure all corporate and departmental policies and procedures are understood and followed by direct reports.
  • Ensure legal and ethical principles and policies are understood and followed by direct reports
  • Manage, oversee, 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, complaint review and approval, customer follow-up and communication, tracking, trending and reporting on the program
    • 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.


  • Bachelor’s Degree with minimum 5 years of relevant experience in a medical device or related industry. Higher level educational degrees (Masters or PhD) are desirable and may count towards
  • Eight (8) or more years of experience in Technical Support or Customer Service and/or Quality Assurance/Regulatory Affairs/Compliance, technical and customer support in a medical device discipline
  • Five (5) or more years of direct supervisory or management experience
  • 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 ART, Cytogenetics, cell and tissue cultures.  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
  • Mammalian Cell & Tissue Culture; Biochemistry
  • Leadership; Decision Making
  • Financial Management
  • Communications Proficiency; Presentation Skills
  • Ability to analyze situations with strategic and creative thinking skills
  • Ability to speak, read and write English proficiently
  • Additional language skills are preferred
  • Good oral and written communication skills

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 

  • While performing the duties of this job, the employee is regularly required to sit, talk with customer and regulatory auditors or agency representatives and other business contacts on the telephone frequently; therefore, the ability to hear well is essential.
  • The employee frequently is required to read, compile, compute, and record numerical and statistical data.
  • Must be physically capable of a moderate amount of air travel.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

  • Employees must be familiar with, implement and observe the SOPs related to the job duties.
  • The noise level in the work environment is that of a busy operations office with telephones, computers and printers operating and with frequent people interruptions.
  • Some exposure to manufacturing and lab settings are inherent with position

Salary and Benefits:

  • $101,000 – 141,000 $182,000 depending on experience
  • Medical, Dental, Vision
  • Life Insurance
  • 401k
  • Paid Time Off



Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.


To all agencies: Please, no phone calls or emails to any employee of Fujifilm about this requisition. All resumes submitted by search firms/employment agencies to any employee at Fujifilm via-email, the Internet, or in any form and/or method will be deemed the sole property of Fujifilm, unless such search firms/employment agencies were engaged by Fujifilm for this requisition and a valid agreement with Fujifilm is in place. In the event a candidate who was submitted outside of the Fujifilm agency engagement process is hired, no fee or payment of any kind will be paid.

© 2023 FUJIFILM Irvine Scientific. All rights reserved.