Document Control Coordinator - 1st Shift - Starting at $26.55/hr

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

Schedule

1st Shift, Monday to Friday start time between 8AM - 5:00PM
Overtime based on business needs

What you will do -

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 companywide 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.
  

What you need -

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.

Preferred qualifications

• 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, MasterControl, NetSuite, Procurify, or similar systems.


• SolidWorks or CAD experience.

$26.55 - $35.91 USD Hourly plus bonus eligible + benefits.