Summary of Primary Responsibilities:
The Document & Training Specialist is responsible for activities required to maintain regulatory compliance related to document management and employee training at the Sports Med site. The position will be responsible for routine activities as well as helping to define the strategic vision and best practices for the effective management of documentation and training. This position serves as the site’s subject matter expert in good documentation practices and training records management.
- Maintain effective collaboration with internal colleagues to drive process improvement in document management and training.
- Assist with quality management system integration into a centralized corporate QMS.
- Oversee the creation of new and revised documents taking into consideration relevant standards and regulatory requirements to ensure compliance.
- Ensure document and record-keeping processes are followed in accordance with company procedures and regulatory requirements.
- Manage the biennial document review process to ensure the appropriate stakeholders are involved and that on-time completion is achieved.
- Monitor changes in external standards and regulations to drive updates in site documentation and training.
- Participate in internal and external audits by providing documents and training records and by maintaining a log of reviewed documents/records.
- Maintain employee training records for the site which includes preparing training schedules, monitoring training compliance and collecting, analyzing and reporting on training metrics.
- Willing to assist with other duties as assigned.
Works independently and exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Bachelor’s degree in, life sciences or related experience in medical device quality management systems.
- Minimum 5 years’ medical device document management experience.
- Knowledge of FDA QSR, ISO 13485, EU MDD and MDR requirements. MDSAP a plus.
- Proficiency working in electronic quality management systems and ERP systems required. Familiarity with SAP, MasterControl and SharePoint desirable.
Desired Experience, Knowledge, and Skills:
- Must be detail oriented and employ logical reasoning when making decisions.
- Is highly organized and able to execute on multiple priorities in a fast-paced environment.
- Possess excellent verbal and written communication skills.
- Be goal-oriented and able to work autonomously to complete tasks in a timely manner.
- Prior experience managing database systems and electronic documentation and training management systems.
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.