2 Document Control Specialist 3 Jobs in Sunnyvale, CA
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Amick Brown, LLC is Hiring a Document Control Specialist 3 Near Sunnyvale, CA
- The Document Control Specialist 3 is responsible for assisting the Document Control lead and manager in maintaining and continuously improving the Document Control Quality System in order to support the business and release of marketed products, meet regulations and established requirements.
- Ensures that product and product related documents are processed through the Agile database in compliance with established procedures, Engineering Change Orders (ECOs), Manufacturing Change Orders (MCOs), Deviations and Engineering Change Requests (ECRs).
- This role requires sedentary and repetitive working conditions.
- Process documentation changes in Agile: Ensure electronic capture and retrieval of quality documents and records by reviewing, evaluating and processing changes accurately and in a timely manner while ensuring that they meet the department goals and objectives
- Audit changes for accuracy and completion. Review changes to ensure that language used in the change is adequate and in compliance.
- Ensure that changes are in a closed loop and all discrepancies (if any) are addressed and closed before the change is released
- Provide clear and accurate communication to internal customers.
- Clearly communicate both verbally and in writing, with Originators when discrepancies are found.
- Give precise guidance to originators for the proper process to follow when to correct issues/discrepancies.
- Provide Agile and change procedure training support as needed to co-workers within and outside Document Control
- Promptly respond to questions and issues raised by Originators and Approvers
- Work with ECO Coordinator to select changes for CCB meetings based on production impact
- Represent Document Control at CCB meetings
- Work with ECO Coordinator and Originators in following-up, analyzing and helping to resolve open ECO/MCO issues
- Provide continuous improvement of Document Control processes/procedures in accordance with department and company goals
- Familiarity with Design History requirements and documents
- Experience with and, clear understanding of the Quality System Regulations and ISO 13485 requirements
- Lead/participate in projects/assignments that support continuous improvement efforts and department/company goals
- Provide change control training (processes and system) to users
- Maintain change control training materials up to date
- Create and maintain change control metrics and reports
- High school diploma
- College degree is preferable
- 5 years’ experience working in Document Control in a Regulatory or Quality organization with a minimum of 3 years at medical device company
- Experience processing changes using an electronic documentation system
- Proficient using Word and Excel applications, and Windows operating system
- Experience using Agile
- Must be able to work effectively in a fast paced, team oriented environment
- Ability to work independently with minimal supervision
- Demonstrated ability with database applications.
- Proficient using Word and Excel application, and Windows operating system
- Demonstrated cross-functional teamwork skills
- Self-starting, detailed oriented, and ability to focus on task at hand
- Ability to work independently with multiple departments to resolve Document Control issues
- Well-developed English written and verbal communication skills
- Product Lifecycle Management (PLM) Processes and System
- Change Control Management
- Quality System Regulations
- ISO 13485 2016
- Health
- Vision
- Dental
- 401k with company match
- Paid time off.
- Sick Leave
- Long -Term Disability
- Life Insurance
- Wellness & Discount Programs
Job Summary
Full Time
IT Outsourcing & Consulting
$82k-116k (estimate)
08/26/2022
06/20/2023
amickbrown.com
San Ramon, CA
25 - 50
IT Outsourcing & Consulting
Related Companies
The job skills required for Document Control Specialist 3 include ISO, Change Control, ERP, Quality Control, Verbal Communication, Continuous Improvement, etc. Having related job skills and expertise will give you an advantage when applying to be a Document Control Specialist 3. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Document Control Specialist 3. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Document Control Specialist 3 positions, which can be used as a reference in future career path planning. As a Document Control Specialist 3, it can be promoted into senior positions as a Document Control Analyst III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Document Control Specialist 3. You can explore the career advancement for a Document Control Specialist 3 below and select your interested title to get hiring information.
If you are interested in becoming a Document Control Specialist, 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 Document Control Specialist for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Document Control Specialist job description and responsibilities
Document control specialists store, manage and track records and documents for government agencies and engineering firms.
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A document control specialist makes sure their organization follows document retention policies and retrieves those documents upon request.
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Document control specialists must also manage the computer software used to manage the organization’s documents.
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Document Control Specialists are also responsible for scheduling, labeling, filing, pulling, distributing, and recovering documents.
03/27/2022: Bakersfield, CA
Provide business support through the analysis and coordination of document control and change control for design, processes and documents.
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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 Document Control Specialist jobs
An outstanding document control specialist checks the promptness and approval of documents, and ensure their timely turn over.
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A document controller specialist who never opens the documents to check them only does half of the job.
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Obtain a strong experience as a document controller.
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Must be willing to perform repetitious tasks such as updating forms, filing logs, copying and scanning documents.
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Document control specialists will need to have a deep understanding of all the latest regulations and how to meet their requirements.
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Step 3: View the best colleges and universities for Document Control Specialist.
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