Quality Training & Document Control Specialist II

Integra-Lifesciences

Braintree (MA)

On-site

USD 71,000 - 98,000

Full time

4 days ago
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Job summary

Integra LifeSciences is seeking a Quality Systems Specialist II to support site Quality Systems with a focus on Training and documentation control. The role includes delivering instructor-led training, maintaining training materials, and ensuring regulatory compliance across the program.

The position also provides cross-training in Document Control, offering back-up coverage and collaboration with process owners to ensure accurate procedures and audit readiness.

Qualifications

  • Experience in Quality Systems, Training, Document Control, or a related function within a regulated environment.
  • Experience with electronic document management, learning management, or Quality Management System.
  • Strong communication and interpersonal skills, with the ability to explain requirements clearly to employees with varying levels of experience.
  • Comfort presenting information, facilitating training, and engaging groups of learners.
  • Knowledge of ISO 13485 and FDA QSR is preferred.

Responsibilities

  • Training & Learning Support: administer site Training program, curricula, records, and reporting.
  • Serve as a qualified trainer for designated Quality System and site processes with instructor-led training.
  • Develop and improve training materials, job aids, and other learning resources.
  • Support onboarding and role-based training; monitor training compliance and follow up on overdue training.
  • Provide backup coverage for Document Control and other Quality Systems activities as needed.

Skills

Quality Systems
Training
Document Control
Agile PLM
LMS

Education

Bachelor’s degree or equivalent

Tools

Agile PLM
LMS
EDMS

Job description

Integra LifeSciences is seeking a Quality Systems Specialist II to support site Quality Systems with a focus on Training and documentation control. The role includes delivering instructor-led training, maintaining training materials, and ensuring regulatory compliance across the program.

The position also provides cross-training in Document Control, offering back-up coverage and collaboration with process owners to ensure accurate procedures and audit readiness.

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