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Integra LifeSciences Specialist, Quality Documentation in Irvine, California

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

Works in Document Control for managing company documents while ensuring quality, accuracy, and integrity of the hardcopies as well as electronic files.

Comply with quality record retention, safeguard information and retrieve the quality records effectively. File, store, manage and track company documents

for the Quality Management System. Performs scanning, filing, copying to maintain documents and obsolete inactive or older revisions of documents. Help engineer, manager maintain drawings, workorders, DCO etc. for the Quality Management System of the company. Perform administrative task as required. Releases Document Control Change Orders (DCOs). Updates logs and lists. Updates Documentation Control Master List. Prints label and verifies information is correct including lot number, model number, expiration date and barcode information prior to giving to QC.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Reviews work orders, drawings, label for correct information, legibility and accuracy

• Reviews documentation for completeness

• Files, organizes, archives, releases documentation both as hardcopy and electronic files.

• Collect and maintain files of the latest revision level documentation necessary to define product

configuration and control manufacturing processes.

• Maintain computer database file documentation.

• Consult with Engineering, Operations, and other cross-functional team for documentation.

• Consult with Engineering, Operations, and other cross-functional team for documentation requirements.

• Verifies completeness of the DCO requirements prior to release of documents into QMS

• Releases DCOs into the Quality Management System

• Notifies affected persons of the document change control and training required

• Support audit both internal and external audits to verify regulatory and quality compliance

• Excellent verbal and documentation skills

• Updates information on drawings to ensure accuracy

• Stamps documentation to state the current status of documentation: active revision, obsolete, archive, history, controlled copy, etc.

Qualifications:

• Associates Degree or equivalent work experience

• Two (2) or more years of Document Control experience

• Experience in Document Control and medical device start-up

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:

EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.

Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)

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