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

Stryker; Irvine (CA); On-site; USD 37,000 - 49,000; Full time

Benefits offered by this job

Bonus eligible

Benefits

Job summary

Stryker Irvine, CA is seeking a Document Control Coordinator to support Operations, R&D, RA and QA by preparing, reviewing, routing, approving and archiving Quality System documents.

The role emphasizes change orders, file management, logs, and ensuring FDA/ISO 13485 compliance, with onsite first shift and start times between 8:00 AM and 5:00 PM; overtime may be required. Travel 0%.

Qualifications

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

Responsibilities

• Review change orders and related docs to ensure compliance with document and change control procedures.
• Manage hardcopy and digital Quality System files.
• Update and maintain Document Control logs.
• Guide companywide on Quality System and Document Control functions.
• Track and facilitate timely documentation review and implementation.

Skills

Document Control

Microsoft Word

Typing

Technical Writing

Reading Comprehension

Education

4-year college degree

Tools

Propel

MasterControl

NetSuite

Procurify

CAD (SolidWorks)

Job description

Work Flexibility: Onsite

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.

Travel Percentage: 0%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.