Document Control Specialist

Davita Inc.; Merrimack (NH); Hybrid; USD 60,000 - 80,000; Full time

Job summary

A leading company in healthcare technology seeks a Document Control Specialist to manage change controls and support project leads for software and digital initiatives. The role requires effective communication and analytical skills, as well as familiarity with Agile PLM and MS Office, to ensure compliance and accuracy in documentation as per FDA and ISO standards.

Qualifications

• Associates Degree or related experience in engineering documentation.
• Minimum 2-5 years' experience in Document Control.
• Strong knowledge of electronic documentation management system.

Responsibilities

• Manage change control process and provide support to item and change order creators.
• Conduct final configuration verification prior to product release.
• Provide training and guidance for maintaining engineering documentation.

Skills

Communication

Analytical Thinking

Customer Orientation

Education

Associates Degree

Tools

Agile PLM

MS Office

Job description

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview Manage change control process and provide support to item and change order creators. Manage software projects as assigned. Job Responsibilities and Essential Duties *Analyze structure configuration for Design History Files (DHFs) and all Lifecycle Device Master Records (DMRs) for completeness within the database (Agile PLM). The content is driven by standard operating procedures. *Ensure data accuracy and completeness for all Lifecycle Engineering and Manufacturing documentation. *Conduct final configuration verification prior to product release. *Responsible for the approvals and configuration release for DHFs and all Lifecycle DMRs as multi-level complex BOM structures through the change control process, Engineering Change Orders (ECOs) within the database (Agile PLM). *Accountable for ensuring documentation follow GDP and SOP's as defined by Atrium's policies, procedures, and Quality Management System (QMS) to ensure that FDA and ISO standards are consistently met. *Provide training and guidance to employees for creating, maintaining, and obsoleting complex multi-level BOM configurations and engineering documentation within the database (Agile PLM) for DHFs and all Lifecycle DMRs. *Work with project leads to drive software and digital projects to completion. Includes but not limited to software products, mobile applications, and web applications. *Develop, document, and maintain project plans. *Determine resource needs and work with functional managers and FP&A on resource planning. *Organize project team meetings, set meeting agendas, issue minutes, and follow up on action items. Minimum Requirements *Associates Degree or related experience, with direct experience in engineering documentation and BOM structures. *Minimum 2-5 years' experience in Document Control in a QMS regulated industry. *Strong knowledge of electronic documentation management system (Agile PLM preferred). *Advanced computer skills in MS Office applications (Excel, Word) are required. Required Knowledge, Skills and Abilities *Demonstrated ability to communicate effectively, with clear and concise oral and written communication. *Ability to interpret and analyze diverse change orders and assess compliance to standards utilizing independent judgment consistently and appropriately. *Customer driven work ethic with a sense of urgency/priority in responding to business needs. *Advanced computer skills in MS Office applications (Excel, Word) are required. *Strong knowledge of electronic documentation management system (Agile PLM preferred). Supervision/Management Of Others: *N/A Internal and External Contacts/Relationships *N/A Environmental/Safety/Physical Work Conditions *Ensures environmental consciousness and safe practices are exhibited in decisions. Compensation: $25/hr to $30/hr depending on experience LI-Hybrid #LI-YA2

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.