QUALITY ASSURANCE MANAGER jobs in Simi Valley, CA

QUALITY ASSURANCE MANAGER is responsible for the implementation of policies and procedures to ensure adherence to production quality standards. Monitors and audits process, material, and product testing against established standards and conducts a continuous analysis of quality defects and deviations. Being a QUALITY ASSURANCE MANAGER identifies deficiencies or gaps in testing activities and develops solutions to ensure adequate and robust quality processes. Optimizes processes to comply with existing and new regulatory requirements. Additionally, QUALITY ASSURANCE MANAGER typically requires a bachelor's degree. Typically reports to a director. The QUALITY ASSURANCE MANAGER manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a QUALITY ASSURANCE MANAGER typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Quality Assurance Manager - (JP9589)
  • 3 Key Consulting
  • Thousand Oaks, CA FULL_TIME
  • Job Title:   Quality Assurance Manager - (JP9589)
    Location: Thousand Oaks, CA. or Cambridge
    Employment Type:  Contract
    Business Unit: Final Product Technology Quality
    Duration: 1 years (with likely extensions and/or conversion to permanent)
    Posting Date: 12/28/21
    Notes:  Remote pending lift of COVID restrictions

    3 Key Consulting is hiring a Risk Management Senior Associate for a consulting engagement with our direct client, a leading global biopharmaceutical company.

    Job Description:
    These roles will start out remote due to COVID and then will go to onsite, M-F.  Can sit in Thousand Oaks or Cambridge.

    Provide quality oversight with regards to the development and lifecycle management of test and inspection methods and fulfillment of regulatory commitments. Potential scope of products with regards to test and inspection methods includes a wide range of devices, raw material components, and constituent parts, such as: needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will both lead and/or support technical teams to ensure successful method development or remediation and/or fulfillment of regulatory commitments. The role of the Senior Quality Engineer is to provide quality oversight to one or more cross-functional teams to utilize technologies and methodologies that support short-cycle robust development, accelerated compliance efforts, and/or remediation/improvement opportunities. 

    Work cross-functionally and globally with individuals and project teams within Final Product Technologies Quality and the Final Product Technologies Engineering groups and their stakeholders in Marketing, Operations, and Development; Ensure compliance to design controls and fulfillment of user needs during test or inspection method development or design changes, including proper and compliant integration of different subsystems as required. – Provide quality oversight and guidance regarding the development of process control plans and implementation of process improvements/changes. – Work with cross-functional teams to develop, qualify, and transfer physical test or inspection methods. - Provide comprehensive quality guidance and advice to counterparts and stakeholders.


    Why is the Position Open?
    Supplement additional workload on team.

    Top Must Have Skills:
    • Quality Assurance experience.
    • Experience with technical methods.
    • Experience with combination products.

    Day to Day Responsibilities:
    • Review and approve FP Mechanical/Physical methods, method development reports, user requirements, method validation reports and method transfer reports.
    • Provide oversight to ensure accuracy and precision of methods to measure final product specifications.
    • Review material characterization data, work with Regulatory to inform teams of any regulatory requirements that must be met.
    • Facilitate PAI readiness for notified bodies and act as escort.
    • Review method transfers across sites and suppliers to provide quality perspective and approval.
    • Provides advice to regulatory on submission strategies associated with platforms and physical methods.
    • Inform other Quality functions of any material requirements.
    • Provide quality expertise and technical knowledge to Final Product Key External Initiative (KEI).
    • Co-develop training materials for method transfers and stability method transfers with FPT Core Technologies.
    • Co-develop training materials for stability method transfers with FPT Core Technologies



    Basic Qualifications:
    • BS or BE in Engineering and previous experience in the medical device and/or pharmaceutical industries.
    • 8 years current experience with engineering processes/procedures and quality tools.
    • Major contributions to or the leadership of projects from development through the 510k and PMA approval process.
    • Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification/validation, DOE/SPC process optimization & validation (IQ, OQ, PQ), P/DFMEA.
    • Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
    • Experience in test or inspection method design and development.
    • Small scale device assembly and/or benchtop testing experience..
    • Experience with Automated Test Equipment (ATE).
    • Experience with regard to Measurement Systems Analysis/GRR principles, including study design/execution/troubleshooting.
    • Strong critical thinking, problem solving, risk assessment, and risk management skills.
    • Must be capable of working on multiple projects in a deadline driven environment.

    Employee Value Proposition:
    Working at a great biotech/pharma company, working with a dynamic team on challenging concepts, growing your skill set in the role.

    Red Flags:
    No and or minimum QA experience.

    Interview process:
    Video Skype Panel Interview


    We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
  • Just Posted

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QUALITY ASSURANCE MANAGER
  • AFFORDABLE ENGINEERING SERVICES, INC.
  • Ventura, CA FULL_TIME
  • Title: Quality Assurance Manager Position Type: Full Time Location: Naval Base Ventura County Travel: 40% Note: This position is contingent upon contract award from the US Navy. Projected award date i...
  • 22 Days Ago

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Quality Assurance Manager, Biopharma (JP10285)
  • 3 Key Consulting
  • Thousand Oaks, CA FULL_TIME
  • Job Title: Quality Assurance Manager, Biopharma (JP10285) Location: Thousand Oaks, CA Employment Type: Contract Business Unit: Combination Products Operations Quality Control Duration: 6 months with l...
  • 11 Days Ago

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Food Safety Quality Assurance Manager
  • Confidential
  • Oxnard, CA FULL_TIME
  • Food Safety & Quality Assurance Manager must be knowledgeable about all food safety standards that are customary within the food industry and mandated by government regulations. Common standards manag...
  • 11 Days Ago

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Quality Assurance Manager, Biopharma (JP9806)
  • 3 Key Consulting
  • Thousand Oaks, CA FULL_TIME
  • Job Title: Quality Assurance Manager, Biopharma (JP9806) Location: Thousand Oaks, CA. or Cambridge Employment Type: Contract Business Unit: Final Product Technology Quality Duration: 1 years (with lik...
  • Just Posted

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Quality Assurance / Quality Control Supervisor
  • Healthcare Components Group
  • Simi Valley, CA FULL_TIME
  • ABOUT HEALTHCARE COMPONENTS GROUP Healthcare Components Group is dedicated to the design, manufacturing, and supply of quality components and solutions for the healthcare industry. With almost 100 yea...
  • 1 Day Ago

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0 QUALITY ASSURANCE MANAGER jobs found in Simi Valley, CA area

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Senior Quality Assurance Engineer Comp Package $160k
  • Amtec Inc.
  • Oxnard, CA
  • SUMMARY Responsible for developing and implementing assigned sections of the quality Assurance Program. Plans and direct...
  • 4/17/2024 12:00:00 AM

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Program Coordinator
  • Yoh, A Day & Zimmermann Company
  • Culver City, CA
  • Job Description Job Description Program Coordinator needed for a contract opportunity with our Entertainment client loca...
  • 4/17/2024 12:00:00 AM

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Research Coordinator (MLIS Required)
  • Fawkes IDM
  • Los Angeles, CA
  • This position may work 100% virtual/remote in a firm approved U.S. state working Pacific or Mountain Time hours. Respons...
  • 4/17/2024 12:00:00 AM

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Program Coordinator
  • Tucker Parker Smith Group (TPS Group)
  • Culver City, CA
  • Program Coordinator (Entertainment) Culver City, CA (Hybrid) Pay Rate: $35/hr. 6 month assignment, opportunity to go FTE...
  • 4/15/2024 12:00:00 AM

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Clinical Research Coordinator
  • Men's Health Foundation
  • West Hollywood, CA
  • Job Title: Clinical Research Coordinator Hourly Range: $25.24 - $33.65 Worker Category: Full-Time FLSA Classification De...
  • 4/15/2024 12:00:00 AM

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Quality Assurance Manager
  • AppleOne Employment Services
  • Camarillo, CA
  • Golden opportunity for a Quality Manager! Role is on-site in Camarillo, CA. Great benefits and amazing company culture! ...
  • 4/13/2024 12:00:00 AM

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Program Coordinator
  • Milken Family Foundation
  • Santa Monica, CA
  • The belief that young people are not only our greatest natural resource, but our greatest national resource has been the...
  • 4/13/2024 12:00:00 AM

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Public Assistance Sr Grant Coordinator
  • Hill International
  • Los Angeles, CA
  • Job Description Hill International is seeking a Public Assistance Sr Grant Coordinator in Los Angeles, California Respon...
  • 4/13/2024 12:00:00 AM

Simi Valley is a city located in the very southeast corner of Ventura County, bordering the San Fernando Valley in Los Angeles County, and is a part of the Greater Los Angeles Area. The City of Simi Valley basically consists of the eponymous valley itself. City of Simi Valley borders the Santa Susana Mountains to the north, the Simi Hills to the east and south, and is adjacent to Thousand Oaks to the southwest and Moorpark to the west. Simi Valley is connected to the nearby San Fernando Valley by the Santa Susana Pass in the extreme east of Simi Valley. Simi Valley is located at 34°16'16" Nort...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for QUALITY ASSURANCE MANAGER jobs
$129,652 to $169,467
Simi Valley, California area prices
were up 2.5% from a year ago

QUALITY ASSURANCE MANAGER in Juneau, AK
Whatever type of industry you work in, be it retail, health care, software, manufacturing or another industry, chances are that a quality assurance manager helps your business meet and exceed quality-control standards for your services and products.
December 23, 2019
QUALITY ASSURANCE MANAGER in Great Falls, MT
In larger companies, quality assurance managers usually lead an entire department or sector, and they hire employees as part of their duties.
February 13, 2020
QUALITY ASSURANCE MANAGER in Baltimore, MD
Having studied your organization in detail, you not only have an outstanding reputation within the industry, but you are clearly serious about setting and maintaining high Quality Assurance standards.
February 02, 2020