Change Management Specialist jobs in Ventura, CA

Change Management Specialist enables organization to achieve greater flexibility and attain competitive advantages by leveraging its human capital. Conducts needs analysis and resource allocation studies to determine most effective use of human capital resources. Being a Change Management Specialist makes recommendations to top management based on research. Demonstrates expertise in a variety of the field's concepts, practices, and procedures. Additionally, Change Management Specialist requires a master's degree in area of specialty. Typically reports to top management. The Change Management Specialist 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 Change Management Specialist 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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Engineer Senior, Combination Device Life Cycle Change Management (JP12255)
  • 3 Key Consulting
  • Thousand Oaks, CA FULL_TIME
  • Job Title: Engineer Senior, Combination Device Life Cycle Change Management (JP12255)
    Location: Thousand Oaks, Ca.
    Business Unit: 
    Final Product Technologies Commercial Advancement 
    Employment Type:  Contract
    Duration: 1 years with possible extensions or conversion to FTE

    Rate: $45 - $50/hour W2
    Posting Date: 2/8/24

    Note: Office-based role supporting virtual teams via Webex and phone.
     
    3 Key Consulting is recruiting an Engineer Senior, Drug Delivery Medical Devices for a consulting engagement with our direct client, a leading global biotechnology company.

    Job Description:

    In this vital role you will perform Sustaining Engineering activities of combination products with electromechanical delivery systems. Such activities support the identification, review, assessment, and resolution of deficiencies throughout the product’s life cycle. Responsible for product life cycle change management and ensures design controls are documented in accordance with internal procedures.


    Office-based role supporting virtual teams via Webex and phone.
    Flexibility required when working with global colleagues in various time zones.
    Must be able to travel up to 5% - Would be to Phoeniz AZ if required

    Key Responsibilities:
    • Complete product and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and product design integrity is maintained.
    • Implement change projects according to internal procedures, supervise progress, and communicate status to group leadership.
    • Communicate with Engineering, Manufacturing, Regulatory, and Quality colleagues.
    • Establish experimental protocols, conduct experiments, analyze results.
    • Support technical execution of Design History File (DHF) updates.
    • Establish and maintain relationships with manufacturing site colleagues.
    • Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of material/processes changes.
    • Establish and review specifications/requirements for components, products and processes.
    • Support CAPA investigations.
    • Ensures product conforms to current relevant international standards.
    • Support multi-functional assessment of complaint record.
    • What we expect of you:
      We are all different, yet we all use our unique contributions to serve patients. The technical professional we seek is a collaborative partner with these qualifications.

       
    Basic Qualifications:
    Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience

    Preferred Qualifications
    • Bachelor's degree in Engineering, Science or other technical degree
    • 1-3 years of experience with Medical Device or Combination Products Design Controls, Production, Sustaining Engineering, or Quality role
    • Proven knowledge and experience in Device Design Control, Risk Management, Medical Devices, and Combination Products
    • Experience analyzing patient/user impact
    • Understanding and practical knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971 and relevant industry standards
    • Critical thinking, and problem-solving skills
    • An ability to work independently as well as a member of a team in a fast-paced environment
    • Working knowledge of statistical methods for data analysis
    • Familiar with microcontroller-based firmware, software verification (unit, static, dynamic analysis)
    • Familiar with circuit design, analysis, troubleshooting, and testing, PCB/PCA assembly and fabrication
    • Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering fields
    • The position requires excellent organizational, technical problem solving and communication skills (written and verbal) and the ability to lead external teams
    Top Must Have Skill Sets:
    • Medical device industry experience and regulated work environment experience
    • Medical Device Design Controls experience
    • Root cause analysis experience
    Why is the Position Open?
    Supplement additional workload on team

    Red Flags:

    Poor verbal communication skills

    Interview Process:
    Phone Interview followed by WebEx meeting/panel interview

    We invite qualified candidates to send your resume to 
    recruiting@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.

  • 16 Days Ago

3
Engineer Senior, Combination Device Life Cycle Change Management (JP11969)
  • 3 Key Consulting
  • Thousand Oaks, CA FULL_TIME
  • Job Title: Engineer Senior, Combination Device Life Cycle Change Management (JP11969) Location: Thousand Oaks, Ca. Business Unit: Final Product Technologies Commercial Advancement Employment Type: Con...
  • 13 Days Ago

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Document Management Specialist
  • Advanced Bio-Logic Solutions Corp
  • Thousand Oaks, CA FULL_TIME
  • Top 3 Must Have Skill Sets: *Candidate needs to be able to manage multiple moving parts in a *controlled document environment* Must be able to stick to deadlines/ maintain timelines etc/ (PM related q...
  • 18 Days Ago

I
Configuration Management Specialist II
  • ICI Services
  • Port Hueneme, CA FULL_TIME
  • ICI Services is currently searching for qualified personnel to fill the position of Configuration Management Specialist II at the Naval Surface Warfare Center (NSWC) in Port Hueneme, CA. ICI is an emp...
  • 1 Month Ago

I
Configuration Management Specialist III
  • ICI Services
  • Port Hueneme, CA FULL_TIME
  • ICI Services is currently searching for qualified personnel to fill the position of Configuration Management Specialist III at the Naval Surface Warfare Center (NSWC) in Port Hueneme, CA. ICI is an em...
  • 1 Month Ago

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Logistician Management Specialist
  • Axient, LLC
  • Port Hueneme, CA OTHER
  • Overview Systems Engineering Group (SEG), a wholly owned subsidiary of AXIENT LLC, is seeking enthusiastic candidates wanting to support the defense of our nation. SEG provides an intellectually stimu...
  • 1 Month Ago

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0 Change Management Specialist jobs found in Ventura, CA area

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Remote Sales Consultant
  • Symmetry Financial Group
  • Oxnard, CA
  • Job Description Overview: We are seeking a highly motivated and results-driven Life Insurance Sales Representative, who ...
  • 4/24/2024 12:00:00 AM

F
Sign Production Specialist
  • FastSigns
  • Ventura, CA
  • FASTSIGNS #63301 is hiring for a full-time Sign Production Specialist to join our team! Benefits/Perks: Competitive Pay ...
  • 4/24/2024 12:00:00 AM

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Special Education Teacher
  • LIFELONG LEARNING ADMINISTRATION CO
  • Ventura, CA
  • Job Details Job Location Ventura [036] - Ventura, CA Position Type Regular Full-Time Job Shift Day Job Category Certific...
  • 4/23/2024 12:00:00 AM

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Rev Cycle Operational Analyst
  • Luminous Technology Group
  • Ventura, CA
  • Company Description Job Description This position requires 2-3 days on-site per week in Ventura. Job Summary: The Revenu...
  • 4/22/2024 12:00:00 AM

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Continuous Improvement Specialist (Manufacturing Resource)
  • Tropicana Brands Group
  • Oxnard, CA
  • About Tropicana Brands Group The launch of Tropicana Brands Group represents an exciting fusion of some of the world's m...
  • 4/21/2024 12:00:00 AM

J
Senior Planner
  • Johnson Service Group
  • Camarillo, CA
  • Job Description Job Description JSG is hiring a Senior Planner (BS Degree Required for our client in Camarillo, CA! Sala...
  • 4/20/2024 12:00:00 AM

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Apartment Occupancy Specialist
  • Investment Property Group
  • Oxnard, CA
  • Hey YOU! We dare you to quit your boring job. We have the perfect position for you. Let's talk. Now is the time to make ...
  • 4/20/2024 12:00:00 AM

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Specialist Manufacturing, New Product Introductions
  • Amgen
  • Thousand Oaks, CA
  • **HOW MIGHT YOU DEFY IMAGINATION?** Youve earned your degree. How will you use that achievement to reach your goals? Do ...
  • 4/20/2024 12:00:00 AM

Ventura is located northwest of Los Angeles on the California coast. The western portion of the city stretches north along the Ventura River and is characterized by a narrow valley with steeply sloped areas along both sides. The steep slopes of the Ventura foothills abut the northern portion of the community. Much of the eastern portion is on a relatively flat alluvial coastal plain lying along the western edge of the Oxnard Plain. The Santa Clara River forms the city's southerly boundary with the city limits reaching up to the beginning of the Santa Clara River Valley at the historic communit...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Change Management Specialist jobs
$134,079 to $194,153
Ventura, California area prices
were up 2.5% from a year ago

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