Document Control Specialist – Quality Systems & Compliance

Stryker Group; Irvine (CA); On-site; USD 37,000 - 50,000; Full time

Benefits offered by this job

Bonus eligible

Benefits

Job summary

Stryker Group is seeking a Document Control Coordinator in Irvine, CA to support Operations, R&D, RA and QA by preparing, reviewing, routing, approving and archiving Quality System documents. The role requires coordinating change orders, managing files, and maintaining logs to ensure regulatory compliance.

You will help to uphold FDA and ISO 13485 standards, mentor others on document control best practices, and drive timely document reviews and implementations in a busy manufacturing environment.

Qualifications

• Minimum 2 years Document Control experience or 4-year college degree.
• Proficient in Microsoft Word; strong writing and communication skills.
• Ability to read, understand, and relay technical information accurately.

Responsibilities

• Review change orders and related documentation for compliance with change control procedures.
• Manage hardcopy and digital Quality System files.
• Update and maintain Document Control logs and records.
• Guide companywide on Quality System and Document Control functions.
• Track and facilitate timely documentation review and implementation.
• Verify completion of DCO/ECO activities and ensure closure and retention timelines.
• Assist in ensuring FDA and ISO 13485 compliance.
• Communicate corporate documentation updates via CIDT process.
• Host meetings to prioritize Change Orders and track milestones.
• Perform other related duties as needed by management.

Skills

Document Control

Quality Systems

MS Word

Technical Writing

Education

4-year college degree

Tools

Propel

MasterControl

NetSuite

Procurify

SolidWorks

Job description

Stryker Group is seeking a Document Control Coordinator in Irvine, CA to support Operations, R&D, RA and QA by preparing, reviewing, routing, approving and archiving Quality System documents. The role requires coordinating change orders, managing files, and maintaining logs to ensure regulatory compliance.

You will help to uphold FDA and ISO 13485 standards, mentor others on document control best practices, and drive timely document reviews and implementations in a busy manufacturing environment.