We are seeking a bright, energetic and detail-oriented individual to join our team as a QUALITY ASSURANCE ADMINISTRATIVE ASSOCIATE. This is an exciting role that will serve as the primary quality partner for Complaint Handling Unit and Regulatory Affairs Team. The position reports directly to the Manager, Quality Assurance Compliance.
The ideal candidate will be someone that enjoys working as part of a fast paced, cross-functional team, balancing multiple tasks and focused on achieving results. This team members will lead by example with a positive, can-do attitude and will apply their critical thinking skills when getting things done. This individual must be able to communicate with team members at all levels.
In addition to those skills and attributes, we’re looking for someone that thrives in a rapidly growing environment and is interested in developing and advancing their career along with the organization.
RESPONSIBILITIES:
- Supports complaint handing investigation process by coordinating the complaint handling unit meetings, maintaining meeting minutes, following up with team members on outstanding deliverables, maintaining the complaint investigation database and track tools.
- Supports post market surveillance by coordinating the collection of post market surveillance information, maintaining databases and records required for post market reporting and periodic safety update reports.
- Supports field action activities by coordinating internal documentation reviews, tracking corrective actions, and coordinating communication to regulatory authorities.
- Works closely with Regulatory Affairs and Quality Assurance Compliance by completing of assigned tasks in accordance with procedures and within the designated timelines.
- Assist in the organization records and sets up filing for these records.
- Serves as backup support for document management and training system administration.
- Identifies gaps in documentation and brings them to the attention of QA team for resolution. May assist in the coordination of resolution and communication with individuals with associated deliverables.
- Supports audit preparation activities by collecting and organizing documentation and records for the audit coordinator, maintain the auditor control area and audit control log.
SKILLS AND EXPERIENCE:
- An Associate’s or Bachelor’s degree in Science, Business or Project Management or 2-4 years of work experience in project and database management. Technical writing experience strongly preferred.
- High proficiency required with MS Office applications. SmartSheet experience preferred.
- Demonstrate knowledge of documentation control processes and eQMS systems preferred.
- Knowledge of GMP and ISO 13485 preferred.
- Medical device experience preferred.
- Excellent time-management, organizational and communication skills. Ability to work with different groups within the organization.
- Ability to work independently, follow instructions accurately, and ask questions if instructions are unclear or circumstances are not as expected.
- Must enjoy multi-tasking and have a positive attitude.
- Comfortable working in a fast-paced work environment.
Required Skills
Required Experience