Quality Compliance Specialist II - Training & Document Control
About The Position
Integra LifeSciences is seeking a Quality Systems Specialist II to support its site Quality Systems organization, primarily administering and executing the site Training program and providing additional Document Control support. The role manages training assignments, curricula, records, reporting, follow-up, and compliance activities. It also serves as a trainer for designated Quality System and site processes, delivering instructor-led training and helping employees understand and apply procedural requirements. The position develops and maintains training resources, partners with process owners and subject matter experts to ensure accurate content, supports onboarding and role-based training, monitors compliance, resolves training-related issues, and assists with audit and inspection readiness. The role is cross-trained to support Document Control based on workload and business needs, including Agile document workflows, document and change-control support, record administration, metrics, data quality, and process improvement.
Requirements
- Bachelor’s degree or equivalent combination of education and relevant experience.
- Experience in Quality Systems, Training, Document Control, or a related function within a regulated environment.
- Experience working within an 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.
- Ability to present information, facilitate training, and engage groups of learners.
- Strong organizational skills and attention to detail, with the ability to manage multiple priorities and follow activities through completion.
- Ability to work independently while collaborating effectively across functions.
Nice To Haves
- Experience in the medical device, pharmaceutical, biotechnology, or another highly regulated industry.
- Knowledge of Quality Management System requirements, including ISO 13485 and/or FDA Quality System requirements.
- Experience administering or supporting employee training within a regulated environment.
- Experience developing or delivering instructor-led training.
- Experience with Agile PLM or a similar electronic document/change-control system.
- Experience supporting audit or regulatory inspection readiness.
- Demonstrated interest in process improvement and identifying more efficient ways of working.
Responsibilities
- Administer the site Training program, including training assignments, curricula, records, reporting, and follow-up.
- Deliver instructor-led, group, and individual training as a qualified trainer for designated Quality System and site processes.
- Develop, maintain, and improve training materials, presentations, job aids, and other learning resources.
- Partner with process owners and subject matter experts to ensure training content reflects procedural and regulatory requirements.
- Support onboarding and role-based training for new and existing employees.
- Monitor training compliance and follow up on overdue, incomplete, or otherwise noncompliant training.
- Investigate and resolve training-related issues, including assignment, curriculum, documentation, and system discrepancies.
- Support training-related audit and inspection readiness, including retrieval and review of training records.
- Identify opportunities to improve training effectiveness, employee understanding, and the user experience of the Training program.
- Support Agile document workflows, including processing and routing document and change orders.
- Review documentation for completeness and compliance with applicable procedures before routing or approval.
- Provide Agile system support and assist users with document and change-control activities.
- Support document administration, data maintenance, and record management activities.
- Provide backup coverage for Document Control and other Quality Systems activities as needed.
- Support Quality System metrics, data quality reviews, reporting, and process improvement initiatives.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Short- and long-term disability insurance
- Business accident insurance
- Group legal insurance
- 401(k) savings plan
- Employees may be eligible for bonus, commission, equity, or other variable compensation, subject to applicable plans.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
