Document Control Specialist

1 week ago


Carlsbad, United States Surf Search Full time

Join our cardiovascular electrophysiology client's rapidly growing team and help as they embark on an exciting phase of their development The company is eager to find a talented Document Control Specialist to manage and maintain quality-related documentation. This position ensures regulatory compliance, oversees version control, and supports communication and training on document changes. The Document Control Specialist also assists with internal and external audits, utilizes Electronic Document Management Systems, and works closely with other departments to maintain adherence to quality management practices.





Qualifications of the Document Control Specialist:

  • High school diploma or equivalent.
  • 7+ years of experience in a regulated industry, preferably biotech or medical device.
  • Knowledge of document control processes, quality assurance, and ISO 13485 Quality Management Systems.
  • Understanding of medical device regulations and good manufacturing practices.
  • Strong attention to detail and commitment to continuous improvement.





Responsibilities of the Document Control Specialist:

  • Manage the Document Change Order (DCO) Process for the release, approval, distribution, maintenance, retrieval, and storage of quality system documents and records in accordance with Standard Operating Procedures.
  • Support the Change Control Board (CCB) to process DCOs, implement changes, complete product disposition, and oversee timely completion of DCO activities.
  • Maintain and support compliance activities related to the Quality Management System (QMS) in line with international and domestic regulations.
  • Manage the employee training program and maintain the training matrix by collaborating with hiring managers to ensure current training records, job descriptions, and employee files are in compliance.
  • Maintain control of electronic and hard copies of documents, including SOPs, product specifications, inspection procedures, clinical documentation, process validation, and more.
  • Update and maintain the Master Document List and Document Change Control Logs to ensure accurate record-keeping.
  • Support and maintain Design History Files, Regulatory Technical files, Device Master Records, and other required documentation.
  • Assist with internal audits in compliance with internal audit procedures.
  • Maintain quality system databases to provide quality metrics and summaries for management review and other meetings as required.
  • Assist during external audits by regulatory bodies (e.g., FDA, Notified Body, California State Department of Public Health).
  • Support product development projects to ensure compliance with regulatory requirements.
  • Provide assistance during regulatory submissions and communication with agencies such as the FDA and Notified Body.
  • Perform other duties as assigned.





Occupational Code: 15-1299.03 Document Management Specialists



  • Carlsbad, United States Surf Search Full time

    Join our cardiovascular electrophysiology client's rapidly growing team and help as they embark on an exciting phase of their development! The company is eager to find a talented Document Control Specialist to manage and maintain quality-related documentation. This position ensures regulatory compliance, oversees version control, and supports communication...


  • Carlsbad, United States Meet Full time

    The Document Control Specialist manages and maintains quality-related documentation, including SOPs and work instructions. This role ensures compliance with regulatory standards, oversees version control, and facilitates communication and training on document changes. The Specialist supports internal and external audits, utilizes Electronic Document...


  • Carlsbad, United States Meet Full time

    The Document Control Specialist manages and maintains quality-related documentation, including SOPs and work instructions. This role ensures compliance with regulatory standards, oversees version control, and facilitates communication and training on document changes. The Specialist supports internal and external audits, utilizes Electronic Document...


  • Carlsbad, United States Precision NDT LLC Full time

    Job DescriptionJob DescriptionA document control specialist is responsible for managing and storing a company's documents. They may also be responsible for:Scanning, imaging, and organizing documentsArchiving inactive documentsReviewing and organizing documentsProcessing requests for informationOrganizing and processing formsEnsuring document storage...


  • Carlsbad, United States Surf Search Full time

    Join our cardiovascular electrophysiology client's rapidly growing team and help as they embark on an exciting phase of their development! The company is eager to find a talented Document Control Specialist to manage and maintain quality-related documentation. This position ensures regulatory compliance, oversees version control, and supports...


  • Carlsbad, United States Meet Full time

    Job SummaryWe are seeking a highly organized and detail-oriented Document Management Specialist to join our team. The successful candidate will be responsible for managing and maintaining quality-related documentation, ensuring compliance with regulatory standards, and facilitating communication and training on document changes.Key ResponsibilitiesDocument...


  • Carlsbad, United States Nortek Control LLC Full time

    ** Tech Support Specialist** **Job Category****:** Technical Support **Requisition Number****:** TECHS002244 Showing 1 location **Job Details** **Description** *Nortek Control has a great benefits package! In addition to health care benefits such as medical, dental and vision and 11 paid holidays, we also have a gym reimbursement program as well as an...


  • Carlsbad, United States INTECH Full time

    Position Overview:INTECH Process Automation is seeking an Automation Control Specialist who will play a pivotal role in the design, development, installation, management, and maintenance of systems used to monitor and regulate engineering operations, machinery, and processes.Key Responsibilities:- Analyze operational processes and devise strategies for...


  • Carlsbad, United States INTECH Full time

    Position Overview:INTECH Process Automation is seeking an Automation Control Specialist who will primarily focus on the design, development, installation, management, and maintenance of systems utilized for monitoring and controlling engineering operations, machinery, and processes.Key Responsibilities:- Innovating and developing new automation control...


  • Carlsbad, California, United States KYYBA Full time

    Logistics and Inventory Control Specialist Job DescriptionKYYBA is seeking a dedicated Logistics and Inventory Control Specialist to enhance our operations. In this role, you will play a crucial part in managing the timely and precise dispatch of our goods, while also confirming the accuracy of incoming deliveries to ensure exceptional client...


  • Carlsbad, United States Kinovate Life Sciences, Inc. Full time

    Job DescriptionJob DescriptionPosition Title: Quality Control Specialist IIReporting to: Quality Control ManagerSummary of Job:The incumbent in this position is responsible for performing routine quality control duties, performing validation experiments as assigned, conducting experiments at various time points for stability studies, data analysis and report...


  • Carlsbad, CA, USA, United States Willdan Full time

    About the RoleWilldan is seeking a highly skilled Energy Efficiency Controls Specialist to join our team. As a key member of our organization, you will be responsible for delivering systems and solutions focused on energy efficiency and optimization of commercial, industrial, and mission-critical facilities.Key ResponsibilitiesCollaborate with Building...


  • Carlsbad, United States Aerotek Full time

    **Job Summary:**Aerotek is seeking a skilled Packaging Specialist to join our team on the 2nd shift. As a Packaging Specialist, you will be responsible for carrying out Standard Operating Procedures involved in high efficiency manufacturing, visual inspection, material handling, and inventory control.**Key Responsibilities:**Operate various equipment such as...


  • Carlsbad, New Mexico, United States Los Alamos Technical Associates Full time

    Job Summary:Los Alamos Technical Associates is seeking a highly skilled Certified Health Physicist to provide technical support to the WIPP Radiological Controls department. The successful candidate will be responsible for ensuring radiological support for WIPP operations is conducted in accordance with approved procedures and regulatory requirements.Key...


  • Carlsbad, United States Proclinical Staffing Full time

    Job DescriptionJob Title: Materials Coordinator IJob Type: ContractLocation: Carlsbad, CACompany: Proclinical StaffingAbout Us: Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.Job Summary:We are seeking a...

  • Warehouse Lead

    2 months ago


    Carlsbad, United States Platinum Control Full time

    Job DescriptionJob DescriptionPosition: Warehouse LeadLocation: Carlsbad, NMPay: $26.38 - 31.00 Per HourStatus: Non-ExemptSupervisor: Facilities ManagerThe Warehouse Lead works under the supervision of the Facilities Manager, as a member of the administrative team. The administrative team provides services and completes projects and duties that ensure...


  • Carlsbad, New Mexico, United States SIMCO Full time

    Join Our Team as an Automation EngineerAt SIMCO, we pride ourselves on being a leading organization in the management and operation of critical waste disposal systems. We are currently looking for an Automation Engineer to enhance our Safety Significant Confinement Ventilation System. This role is essential in supporting our government clients in the field...


  • Carlsbad, United States Pharmaron Full time $24 - $27

    Job DescriptionJob DescriptionPosition: Quality Control AssociateDepartment: Quality ControlFLSA Status: Non-ExemptLocation: Carlsbad, CA (On-site)Job Overview: The Quality Control Associate is responsible for assisting with the review of study data for consistency, accuracy, and completeness. The QC Associate is also responsible for ensuring proper...


  • Carlsbad, United States Pacific Western Bank Full time

    OverviewPacific Western Bank is a prominent financial institution dedicated to providing exceptional banking and treasury management services tailored for small to middle-market businesses. Our commitment to fostering relationships with our clients is at the core of our operations.Job SummaryThe Senior Loan Servicing Specialist is responsible for overseeing...


  • Carlsbad, California, United States Means Engineering, Inc. Full time

    Job OverviewPosition SummaryThe Quality Assurance Inspector plays a crucial role in ensuring that products meet stringent quality standards and customer specifications. This position involves conducting various inspections including receiving, in-process, final, and shipping inspections under direct supervision.Key ResponsibilitiesConduct thorough...