About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About the role

·         The Document Control Specialist is responsible for managing, maintaining, and controlling quality system documentation in accordance with company procedures and applicable regulatory requirements for the medical device industry. This role ensures that all controlled documents, records, and quality system files are accurate, current, approved, and readily available to the appropriate personnel.

What you'll do

• ·         Successfully contribute to projects teams according to the engineering necessity of the client, including activities like product design and development, test of materials, preparation of specifications, process capability studies, research investigations, report preparation, process/test documentation, etc.
• ·         Experienced and proficient with quality documentation in order to develop, review and approve quality documentation such as: design verification, design validation, process validation, quality plans, standard operating procedures, and inspection procedures.
• ·         Work cohesively and maintain functional interpersonal relationships with internal and external customers.
• ·         Demonstrate customer service orientation, translate customer requirements into workable product ideas and solutions.
• ·         Adapt to the culture, policies and procedures of the client´s company, be recursive and create strategic alliances to facilitate completion of the assignments.
• ·         Maintain active communication with supervisors and clients.
• ·         Maintain and administer the document control system for quality and operational records.
• ·         Create, revise, route, issue, archive, and obsolete controlled documents, including:  Standard Operating Procedures (SOPs), Work Instructions (WIs), Forms and templates.
• ·         Ensure that all documents are reviewed and approved by the appropriate functions prior to release.
• ·         Verify that document revisions are properly tracked and that only current versions are available for use.
• ·         Maintain document history logs, revision histories, and change control records.
• ·         Support internal and external audits by retrieving, organizing, and presenting controlled documentation.
• ·         Manage document control activities associated with quality system processes such as: CAPAs, non-conformances, deviations, change controls, customer complaints.
• ·         Review validation and CAPA packages for completeness prior to approval and release

What you will bring

• Bachelor’s Degree in Engineering .
• 6+ year of experience.

• Experience managing controlled documentation associated with: CAPAs, non-conformances, change controls, equipment and process documentation

• Familiarity with Good Documentation Practices (GDP).
• Advanced computer skills including MS Office applications (Word/Excel/PowerPoint/Project/Visio)
• Familiar with electronic management documentation.
• Spanish: Native Speaker, English: Fluent speaking, writing and reading.

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.

At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future.  At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity. 

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