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QA Manager (2nd Shift)
FujiFilm Santa Ana, CA
$137k-176k (estimate)
Other | Hardware & Office Equipment 6 Months Ago
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FujiFilm is Hiring a QA Manager (2nd Shift) Near Santa Ana, CA

Overview

FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.

We are hiring a Quality Control Manager (2nd Shift who will manage the Company’s Quality Assurance personnel and activities including incoming QA inspection raw materials, raw material qualification program, change notification, validation, final product release, customer audit management, and various customer and internal support as required.

**

External US

Responsibilities:

  • Manage QA Incoming Inspection function and personnel.
  • Manage product Final Release function and personnel.
  • Manage raw material qualification program including maintenance of data bases and records, and change notification
  • Assist with customer audit program including scheduling, pre- and post-audit activities.
  • Provide customer support in areas such as completion of surveys, providing raw material information, and related QA support.
  • Assist in activities related to the preparation for and conduct of FDA and Notified Body inspections and customer audits.
  • Manage deviations, CAPA and associated actions and status
  • Manage validations planning, coordinating, execution, completion
  • Assist and support Quality Systems management in the conduct of daily operations of the department and within the Company as required.
  • Trend and Analyze Quality Indicators. Provide input as to appropriate corrective and preventive actions and suggest plans for improvement.

Experience/ Education:

  • BS in Microbiology/Chemistry/Biology/Chemical Engineering or equivalent experience preferred.
  • A minimum of ten (10) years of Quality Assurance in medical device manufacturing or equivalent.
  • A minimum of four years in a managerial position
  • Proficiency in current versions of MS Word, Excel
  • Excellent communication and collaboration skills
  • Ensure that requirements are met in all regulatory, compliance and registration functions as prescribed by the FDA’s GMPs (QSR), ISO 13485, MDD 93/42, MDR 2017/745, IVDD 98/79/EC, IVDR 2017/746, ISO 14971, Brazilian GMPs, Health Canada MDR, Australian Medical Device regulations and regulatory requirements for product registrations where products are distributed worldwide.
  • Current industry regulations, i.e. Detailed understanding of 21CFR211-cGMP, FDA QSR 820, ISO13485, Canadian Medical Device Regulations, Brazil and inspection and auditing guidelines.
  • Ability to speak, read, and write English.
  • Good Oral and communication skills.

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.

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.

Job Summary

JOB TYPE

Other

INDUSTRY

Hardware & Office Equipment

SALARY

$137k-176k (estimate)

POST DATE

09/26/2022

EXPIRATION DATE

04/03/2023

WEBSITE

fujifilm.com

HEADQUARTERS

AKASAKA, KANTO

SIZE

3,000 - 7,500

FOUNDED

1962

CEO

SADAKAZU GOTO

REVENUE

$3B - $5B

INDUSTRY

Hardware & Office Equipment

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If you are interested in becoming a QA Manager, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a QA Manager for your reference.

Step 1: Understand the job description and responsibilities of an Accountant.

Quotes from people on QA Manager job description and responsibilities

A quality assurance manager ensures that a product meets the required qualifications to become acceptable.

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Quality assurance managers set basic ground rules such as what testing tools should be use, which methodologies they should apply, and on how to define defect status.

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Establish measurable and reportable criteria for success.

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Evaluate the project when complete.

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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.

Career tips from people on QA Manager jobs

Try to spot possible regression as early as possible.

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Recognize different perspectives.

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Select team members and assign responsibilities carefully.

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You should spend time with team members and provide an honest feedback so they can know the areas that they need to improve.

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