Careers

Technical Support Associate

Technical Support | Santa Ana | CA

Job Function:
We are seeking an individual to assist the Technical Support group in support to internal departments, field employees and external customers. Managing customer complaints and investigation for resolution. Assist with processing and resolving technical issues, and regulatory submissions as needed.

 

Job Duties:

  • Managing and monitoring customer inquiries associated with complaints.
  • Assist with product evaluations by keeping the focus on technical resolution with in-house groups.
  • Assist in process improvement projects to improve effectiveness and efficiency of process directly affecting our customers and their adaptation of our products.
  • Ensuring timely closure of customer complaints and that established turnaround times are met.
  • Ensuring compliance of processes and procedures to applicable standards related to complaints.
  • Provide technical support, as needed, for the preparation of regulatory submissions for FDA/EU/CMDR or other regulatory agencies.
  • Assisting with changes to product design, specification or production processes and reviewing risk analysis files as required.
  • Assisting in the communication with regulatory agencies, notified body, and competent authorities as associated with complaints.
  • Assisting in the development of materials (eg. FAQs) to reduce the number of recurring inquiries on products.
  • Works on complex and challenging problems in which analysis of situation or data requires a review of identifiable factors.
  • Prepare formal reports and presentations.
  • Actively participate in group/project meetings.
  • Update job knowledge by participating in educational opportunities and reading technical publications.


Experience/Education:

  • B.S. in a Biological/Chemical Science or equivalent.
  • 5 or more years of experience in technical, customer support in a medical device discipline.
  • 2 or more years of experience in Quality Assurance/Regulatory Affairs.
  • Experience in cell and tissue culture. Experience can be from education or industry.
  • Ability to obtain cooperation from other groups and lead cross functional teams.
  • Proficient in interpersonal, organizational and time management skills.
  • Proficient in written and oral communication skills; also able to plan and deliver presentations.
  • Proficient in Microsoft Word, Excel, PowerPoint, Outlook.
  • Efficient customer service skills in the best interest of both customer and company.
  • 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 controls systems and production methodologies.
  • Experience with risk management and Failure Mode Effects Analysis (FMEA). Strong root cause analysis skills required.
  • Ability to speak, write and read English fluently.
  • Good oral and written communication skills.

 

To Apply: Please send resume to: fisiirlrecruitment@fujifilm.com. Please put Technical Support Associate 101218 in the subject line.

 

Principals only. No recruiters please.

 

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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