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Document Control Coordinator - 1st Shift
Job in
Irvine, Orange County, California, 92713, USA
Listed on 2026-09-12
Listing for:
Stryker Group
Full Time
position Listed on 2026-09-12
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers
Job Description & How to Apply Below
Schedule
1st Shift, Monday to Friday start time between 8AM - 5:00PM
Overtime based on business needs
-
The Document Control Coordinator supports Operations, R&D, RA and QA activities by preparing, reviewing, routing, approving and archiving Quality System documents as well as the following below:
- Review change orders and associated documentation to ensure compliance to company document and change control procedures.
- Supports the management of hardcopy and digital Quality System files
- Updates and maintains Document Control related logs
- Guides company wide on Quality System, Document Control function
- Tracks and facilitates timely documentation review and implementation.
- Verification of completion of DCO/ECO-related activities, such as material disposition and training to ensure closure of DCO/ECO following completion of these activities.
- Establish and maintain record retention timelines
- Assist ensuring compliance to FDA and ISO 13485
- Assist in communicating corporate documentation updates through the CIDT process
- Host meetings to prioritize Change Order
- Track document milestones and completion.
- Performs other related duties, responsibilities and projects as business needs require at the direction of management.
- Required qualifications
- Minimum 2 years Document Control experience or 4-year college degree.
- Should have good keyboarding skills and be proficient in the use of Microsoft Word.
Possess good writing skills.
Must be able to read, understand and relay technical information accurately and concisely.
- Experience in medical device, pharmaceutical, manufacturing, or quality environments.
- Document Control, Quality Assurance, Records Management, or Compliance experience.
- Experience supporting FDA-regulated or highly controlled environments.
- Experience working with quality management systems and electronic documentation systems.
- Experience with Propel, Master Control, Net Suite, Procurify, or similar systems.
- Solid Works or CAD experience.
$26.55 - $35.91 USD Hourly plus bonus eligible + benefits.
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