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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.

The Coordinator, Quality Assurance reviews all batch records and quality records and ensures products and processes are compliant with all applicable regulations and Standards including but not limited to US FDA, EU, State and local regulations, ISO 13485, and Integra policies and procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Review Pre, Post and Finished Goods batch records for completeness and accuracy.

• Review and approve other assigned quality records within the QMS for completeness and accuracy.

• Communicate issues related to reviewed manufacturing and quality records with the concerning departments for satisfactory resolution.

• Approve manufacturing lots for QA release.

• Ensure that lot specific NCs, CAPAs, Deviation are resolved prior to release of the devices.

• Ensure quality records are properly scanned, filed, secured, and controlled.

• Perform ERP transaction for product nonconformance, product accountability and final product release.

• Assist in the initiation and investigation (including root cause investigation) of NCMR, MRB, CAPA and Deviation processes.

• Perform other related duties as assigned.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

Education & Experience:

• Bachelor’s degree in a related scientific discipline. Strong candidate with relevant experience but with lesser education will also be considered.

• Minimum of 2 years of quality assurance or quality control lab experience in the medical device or similar regulated industry.

• Experience with batch record review and product release.

• Exceptional attention to detail

• Demonstrated organizational skills.

• Strong leadership and analytical skills with a team-focused attitude

• Strong communication skills, both written and verbal

• Knowledge of using Agile, Oracle, FaciliWorks.

• Demonstrated knowledge of cGMP, ISO 13485, and other national and international regulations and standards

• Computer literacy—experience with Microsoft Outlook, Word, Excel, and Access database

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.

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