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Why join Stryker?
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.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Click here to learn more about: US Stryker employee benefits Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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