We are searching for a Quality Assistant who will assist the Quality Manager with the creation, maintenance, and improvement of an ISO 13485 Quality System and other regulatory affairs.
Level of Experience: Entry-Level
Responsibilities
- Assist with document control processes and procedures.
- Assist with internal and external auditing processes.
- Support the preparations for regulatory submissions for devices and products.
- Support teams with quality aspects of ongoing processes like manufacturing, product development, purchasing, verification and validation.
- Work with other teams/departments to develop and update functional documentation.
- Participate in the development and maintenance of SOPs, test procedures, training records, and other quality system related documentation.
- Collect and analyze quality data to quantify the effectiveness of the quality system and identify opportunities to improve processes.
- Support the Quality Manager in the processes of monitoring and reporting on quality system performance.
- Assist with internal and external auditing.
Skills and Qualifications
Required:
- Must demonstrate a working understanding of pertinent quality system regulations (i.e.: GMP, ISO, FDA)
- Analytical and problem-solving skills.
- Excellent verbal and written communication skills.
- Extremely experienced with Microsoft programs like Excel, Word, and PowerPoint.
- Associate degree and/or technical certification, Bachelor’s degree preferred.
- Must be self-motivated, organized, and have the ability to multi-task projects.
Preferred:
- Previous experience with an ISO 13485 quality system
- Experience writing and editing technical documentation.
- Data analysis skills and working knowledge of statistical methods.
- Experience with manufacturing and design documentation.
- Experience in a research and development environment.
Benefits
Our company offers to its employees:
- 401(k)
- PTO
- Dental Insurance
- Health Insurance
- Vision Insurance
- Life Insurance
- Flexible Schedule
