Document Control Coordinator 1st Shift Starting at 26.55hr
Irvine, CA - USA
Job Summary
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 contractors legal duty to furnish information.Required Experience:
IC
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more