Fujifilm Manufacturing USA, Inc

Quality Engineer- Life Sciences

Fujifilm Manufacturing USA, Inc • $106K — $125K *
Santa Ana, CA 92704In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering or equivalent education.
  • 5+ years of relevant work experience in quality engineering.
  • In-depth knowledge of ISO standards and FDA regulations for medical devices or pharmaceuticals.
  • Strong background in deviation/nonconformance investigations and root cause analysis.
  • Proficient in English with excellent oral and written communication skills.

Responsibilities

  • Lead quality event investigations to ensure timely resolution.
  • Facilitate cross-functional meetings to present findings and recommendations.
  • Conduct risk assessments and verify effectiveness of quality initiatives.
  • Utilize statistical tools for data analysis related to quality and process monitoring.
  • Generate and revise quality-related documents such as SOPs.
  • Support audits and CAPA investigations to enhance process improvements.
  • Collaborate with cross-functional teams to meet KPIs and objectives.

Benefits

  • Medical, Dental, and Vision insurance.
  • Life Insurance provided.
  • Retirement savings plan (401k).
  • Generous Paid Time Off (PTO) policy.
Full Job Description
Position Overview

Position Description

We are hiring a Quality Engineer. The Quality Engineer will be responsible for ensuring quality system compliance by driving the resolution of quality events.

Job Description

Responsibilities:
  • Lead quality event investigations (e.g., NONC and DEV) and ensure timely resolution.
  • Lead cross-functional meetings and present investigation outcomes, quality risks, and recommendations to management.
  • Perform investigations (6M, 5WHY, RCA), risk assessments, and verifications of effectiveness.
  • Compile and analyze data utilizing statistical tools and techniques for quality events and process monitoring.
  • Generate and revise documents (e.g., SOPs).
  • Support audits, corrective and preventative action (CAPA) investigations, and process improvement initiatives.
  • Collaborate effectively with cross-functional teams to achieve KPIs and objectives.
  • May be required to perform other duties as needed.

Required Skills/Education:
  • A minimum of a Bachelor's degree or equivalent in an Engineering discipline.
  • A minimum of five (5) years of relevant work experience.
  • Knowledge of ISO standards and FDA guidelines/rules/regulations for medical device / pharmaceuticals.
  • Experience with deviation and nonconformance investigations, root cause analysis, CAPA, SCAR, and change control.
  • Ability to speak, read, and write English proficiently.
  • Proficient oral and written communication skills.

Salary and Benefits:
  • For California, the base salary range for this position is $106,185.25- $125,000 per hour. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
  • Medical, Dental, Vision
  • Life Insurance
  • 401k
  • Paid Time Off

*#LI-onsite

About Fujifilm Manufacturing USA, Inc

Fujifilm Manufacturing USA, Inc is a subsidiary of Fujifilm Holdings Corporation, a Japanese multinational conglomerate that specializes in imaging and photography. Fujifilm Manufacturing USA, Inc is responsible for the manufacturing of photographic paper, film, and other imaging products in the United States. The company was established in 1988 and has its headquarters in Valhalla, New York. Fujifilm Manufacturing USA, Inc operates as a subsidiary of Fujifilm North America Corporation.
Learn more about Fujifilm Manufacturing USA, Inc
Size
72,332 employees
Industry
Manufacturing & Automotive
NASDAQ
FUJIF
* Ladders Estimates

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