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Joining us is a chance 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, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY DESCRIPTION

The Lead QA Coordinator, Doc Control/ Training manages the Document Control & Training Management processes and maintains associated procedures in accordance with FDA 21 CFR Part 820, ISO 13485, state and local regulations, and Integra policies and procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Acts in the capacity of Agile Analyst

Manages Change Control ECR/ ECO processes

Manages the Document Control, DCO process.

Owns the Deviation process. Reviews Deviations prior to their approval, releases Deviation as effective and closes Deviations in coordination with the Deviation owners.

Is a point of contact with MasterControl

Communicate with MasterControl support for technical issues.

Enter maintain, and archive users in the MasterControl system and provide support as needed.

Acts as administrator for Training and Competency program

Organize, Implement, and update training competency program and Training Job codes.

Maintain employee training records (hard or electronic) and ensure that training files are current.

Based on the Work Orders printed and provided by the Manufacturing:

Prints corresponding Job Travelers from Agile.

Prints corresponding IFUs from Agile or gets preprinted IFUs.

Applies Master Stamp on printed Job Travelers and IFUs and makes them available to manufacturing.

Writes and reviews QMS SOPs as necessary.

Administers elements of the site quality system in relationship to the corporate quality system and makes revisions as needed.

Conducts trend analysis of QA activities and other quality indicators as needed.

Ensures all document control quality records are appropriately filed and easily retrievable in the quality department, and/ or Agile/ Master Control software.

Performs other related duties as assigned.

REQUIRED SKILLS & KNOWLEDGE

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

Education & Experience:

Education/ Experience:

Bachelor’s degree or equivalent in a related scientific discipline with 0 - 2 year of relevant work experience; or 

Associate degree, or equivalent in a related scientific discipline with 3 - 5 years of relevant work experience; or

High School degree or equivalent with a minimum of 5 years of relevant work experience

Well informed and proficient in the use of modern technology, especially Electronic Document Management systems (EDMS), Enterprise Resource Management Systems (ERP), and the Microsoft suite of applications.

Experience in MasterControl, Agile and Oracle systems is highly preferred.

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

Strong communication skills, both written and verbal.

Self-motivator with an analytic nature.  Strong organizational, communication, and interpersonal skills. 

Team-focused attitude.

Ability to obtain Quality training and/or certifications as needed.     

Organized, attention to detail and excellent analytical skills.

Excellent communication skills, both written and verbal.

Excellent organization, prioritization and problem-solving skills

Able to lift 40 lbs.

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.

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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. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.

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