Quality Compliance Specialist II - Training & Document Control

TEI BIOSCIENCES INC; Braintree (MA); On-site; USD 71,000 - 98,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) savings plan

Job summary

Integra LifeSciences, based in Massachusetts, seeks a Quality Systems Specialist II to support the site Quality Systems program with a primary focus on Training and additional duties in Document Control. You will administer the training program, manage curricula and records, and deliver instructor‑led training to ensure procedural and regulatory compliance.

The role requires collaboration with process owners, development of training materials, and coverage for document control activities.

Qualifications

• Experience in Quality Systems, Training, or Document Control within a regulated environment.
• Experience with learning management systems and electronic document management.
• Strong communication and ability to explain requirements clearly.

Responsibilities

• Administer the site Training program, assignments, curricula, records, reporting and follow-up.
• Deliver instructor-led training for Quality System and site processes.
• Develop and maintain training materials and job aids.
• Partner with process owners to ensure regulatory content accuracy.
• Support onboarding and role-based training for employees.
• Assist with Agile document workflows (change orders) and document routing.
• Provide backup support for Document Control and other Quality Systems tasks.
• Support audits and inspection readiness for training records.

Skills

Quality Systems

Training

Document Control

Oral & Written Communication

Regulatory Knowledge

Education

Bachelor’s degree or equivalent

Job description

Changing lives. Building Careers. 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. 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 Responsibilities

• 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 non‑compliant 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.
• 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

Additional Description for Pay Transparency

• medical
• dental
• vision
• life insurance
• short- and long-term disability
• business accident insurance
• group legal insurance
• 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.

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 | EOE including Disability/Protected Veterans 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 [e-mail].