This position is responsible for supporting the Quality Assurance Department with Document Control activities to ensure compliance to Quality System Regulations and standards such as; FDA regulations, ISO standards and internal policies. This position will work to maintain elements of Quality Management Systems (QMS) in accordance with ISO 13485 and FDA 21 CFR 820 requirements as well as company protocols.
KEY ACCOUNTABILITIES AND RESPONSIBILITIES
- Adheres to Company Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
- Work in the Document Control System (DCS) shall include; writing of new Quality System documents, maintenance of existing documents, processing document change requests and coordinating the approval of Procedures, Work Instructions and Forms.
- Maintain the Document Change Order (DCO) process to support all sites under the Quality System.
- Perform Document Control activities such as, but not limited to, document review and approval, data entry, filing, maintaining logs, processing documents, scanning documents, checking out and checking in documents and generating process trends.
- As required, assign document identifiers to Quality and Manufacturing document types and provide assistance in creating documents.
- Assist Management with supporting functions relating to; equipment preventive maintenance logs, calibration files and forms.
- Assist Management with supporting functions relating to the training program (data entry, filing training forms, creation of training files).
- Assist with CAPA and Quality Incident trending.
- Performs other functions as required.
- High School diploma or equivalent. Associate’s Degree in a technical field or other technical degree preferred.
- 2-5 years of experience in manufacturing and regulated industry.
- Ability to read and interpret drawings/prints.
- Ability to read and understand work instructions.
- Good verbal communication and organizational skills
At Viant, we focus on providing end-to-end solutions for medical device OEMs. Our deep materials expertise—combined with our experience in engineering, manufacturing, assembly, packaging, and sterilization—allows us to bring our customers’ healthcare solutions to market. We have facilities across the U.S. and around the world, including low-cost facilities in Costa Rica, China, Mexico, and Puerto Rico. Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.