Quality and Regulatory
The quality assurance assistant will be responsible for supporting the Quality and Regulatory Department through Quality System documentation activities.
- Create/Write SOP for training administration
- Organize document control hard copy files
- Scan hard copy records to electronic, such as incoming acceptance records
- Assist with regulatory submissions, through printing, labeling, organizing electronic information
- Enter complaints in electronic database (Arena PLM), based upon team review outcome
- Follow up on the status of action items related to quality processes.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to read, analyze, and interpret general business correspondence, technical procedures, and/or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from coworkers and managers.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
College undergraduate; or Graduate-Level. Engineering focus preferred.
0-3 years prior work experience
Microsoft Office proficiency
Ability to quickly pick up various database tools (Arena, TrainTrack, SalesForce)
Knowledge, Skills and other Abilities:
- Ability to explain, define, and clearly communicate processes.
- Strong written communication skills
- Strong verbal communication skills
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, use hands, and talk or hear. The employee is frequently required to stand, walk and reach with hands and arms. The employee is occasionally required to climb or balance, and stoop, kneel, crouch or crawl.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles, and risk of electrical shock.
The noise level in the work environment is usually mild to moderate.
To apply for this job email your details to firstname.lastname@example.org