Responsibilities
- Under the direction of Quality / New Product Introduction (NPI) or other technical managerial position and depending on the incumbent´s level of knowledge and Education, he/she will assist the engineers in projects related activities such as: documents preparation, documents translations, component specification, item master creations, Test Method Validation (TMV) protocols drafting and/or its execution for the purpose of equipment verification, supported by a Quality Engineer.
- Represent Quality in production process efforts, support the team on FMEA and risk analysis, support new product development activities, maintain and manage quality compliance and supplier quality management, support and collect data for any complaint investigations, NCs or CAPA, collaborate on process improvement and quality assurance testing metrology.
- Participate in Corrective/ Preventive Action, NC investigation and Complaints initiatives supported by Quality Engineer.
- Collect process data for TMVs to assist in transfer, training, validation or other project related works under the guidance of a Quality Engineer.
- Perform inventories whenever prompted (Quality Cages).
- Create Component Specification and Item Master.
- Create First Article Inspections.
- Execute initiation of NC and Complaints as needed.
- Support in the execution of qualifications (TMVs) with an approved protocol, gather data and results for completing the corresponding report, under the guidance of a Quality Engineer.
Knowledge / Education
- Studying an Engineering ,Technical related career or Science (such as Pharmacy, Microbiology, Physics and Chemistry)
- Intermediate knowledge of Microsoft Office package (Word, Excel, Power Point and Outlook).
- Knowledge on ISO 13485:2016 and CFR 820 CGMPs
- Basic English will be considered a plus.
Work Experience
- 1 year of experience in Viant or 3 years in a highly regulated manufacturing environment (medical devices) occupying positions of growing responsibilities.
**Requirements**:
- At least one year in current position.
- No disciplinary actions of less than three months.
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.
