Change Analyst

at  Natus Medical Incorporated

The Change Analyst is responsible for the control of documents in support of products designed, manufactured, or distributed by Natus Medical Denmark A/S or in support of the Natus Quality Management System (QMS).

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Ensuring all controlled documentation is reviewed and approved prior to use per site Change Control Procedure.
• Provide support for document control activities across multiple facilities.
• Ensuring that the current revision status of and changes to the documents are identified.
• Ensuring that the relevant versions of the applicable documents are available at the point of use.
• Ensuring that documents remain legible and readily identifiable.
• Maintaining Internal and External Master Document Lists, including the Quality System Records.
• Promote Good Manufacturing practices and ensure others adhere to the quality system requirements.
• Review company systems and procedures to ensure effectiveness;
• Support the Corrective and Preventive Action Process (CAPA)
• Ensures compliance with all applicable domestic and international regulatory requirements and quality system regulations and standards.
• Assists with the handling of deviations/non-conformances
• Provides education and training as required
• Contribute to continuous improvement of systems and practices
• Auditee for Corporate/Regulatory body/Customer audits

Travel Required: There will be no travel required for this position.

QUALIFICATION REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND/OR EXPERIENCE

Bachelor’s degree from four-year college or university in an engineering or scientific discipline (Electronics, Mechanical or Chemistry Sciences, Physics or related) or two to four years related experience and/or training; or equivalent combination of education and experience.

OTHER SKILLS AND ABILITIES

• Fluent speaking, reading and writing in English.
• Excellent organizational; problem solving; decision making; communication (oral and written); and influencing skills.

• Ensuring all controlled documentation is reviewed and approved prior to use per site Change Control Procedure.
• Provide support for document control activities across multiple facilities.
• Ensuring that the current revision status of and changes to the documents are identified.
• Ensuring that the relevant versions of the applicable documents are available at the point of use.
• Ensuring that documents remain legible and readily identifiable.
• Maintaining Internal and External Master Document Lists, including the Quality System Records.
• Promote Good Manufacturing practices and ensure others adhere to the quality system requirements.
• Review company systems and procedures to ensure effectiveness;
• Support the Corrective and Preventive Action Process (CAPA)
• Ensures compliance with all applicable domestic and international regulatory requirements and quality system regulations and standards.
• Assists with the handling of deviations/non-conformances
• Provides education and training as required
• Contribute to continuous improvement of systems and practices
• Auditee for Corporate/Regulatory body/Customer audit