We are seeking a Quality Systems Specialist II to support our site Quality Systems organization, with a primary focus on the Training program and additional responsibilities supporting Document Control.
This role will support both the administration and execution of the site training program. In addition to managing training assignments, curricula, records, and compliance activities, the Quality Systems Specialist II will serve as a trainer for designated Quality System and site processes, delivering instructor-led training and helping employees understand and effectively apply procedural requirements.
The position will also be cross-trained to support Document Control activities, providing flexible coverage based on workload, business priorities, and team needs.
Key ResponsibilitiesTraining & Learning Support- Support administration of the site Training program, including training assignments, curricula, records, reporting, and follow-up.
- Serve as a qualified trainer for designated Quality System and site processes, delivering instructor-led, group, and individual training as appropriate.
- 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 accurately reflects procedural and regulatory requirements.
- Support onboarding and role-based training for new and existing employees.
- Monitor training compliance and proactively 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 overall user experience of the Training program.
Quality Systems / Document Control- Support Agile document workflows, including processing and routing document and change orders.
- Review documentation for completeness and compliance with applicable procedures prior to 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.
Qualifications- 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.
- Comfort and demonstrated ability presenting information, facilitating training, and engaging 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.
Preferred Qualifications- Experience in the medical device, pharmaceutical, biotechnology, or other 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.
Salary Pay Range:
$71,300.00 - $97,750.00 USD Salary
Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences
