quality engineer Vega Baja, PR
Job description
Viant is a global design and manufacturing services provider for the medical device industry. At Viant, we’re in it for life.
Our focus is to enhance the customer experience by building true business partnerships in our business though, Teamwork, Being Agile, having Personal Integrity, Owning It and Recognizing the Success of others because Together We Are In It For Life.
Are you passionate about being part of a Team that will become the most trusted medical device molding and assembly service provider?
As a Quality Engineer, you will be involved in design, development, compliance and assembly according to medical device combination products specifications. This role is responsible for ensuring that combination product projects are compliant with quality system. The Quality Engineer will serve as a subject matter expert on medical device and combination product requirements in accordance with FDA / MDR regulations, ISO and other standards and industry best practices with the emphasis on Design Control process.
Main Job Responsibility
· Work with project leaders and both internal and external team members to ensure that all design development work meets applicable FDA, EU MDR and other global regulatory requirements.
· Ensure that teams follow the Design, manufacturing and assembly control process and utilize appropriate quality engineering techniques such as risk analysis, statistical data analysis, sampling plan development, etc.
· Ensure external medical device development and manufacturing partners meet the standards and criteria by participating in the audits; reviewing quality or development agreements; monitoring vendor performance.
· Provide regular progress reports and escalate potential risks related to Quality System and/or project status to Quality management.
· Stay abreast of changing regulatory requirements for medical device and combination products.
· Maintain systems / databases related to the combination products, as assigned.
Job Types: Full-time, Contract
Salary: $48,000.00 - $50,000.00 per year
Ability to commute/relocate:
- Vega Baja, PR 00694: Reliably commute or planning to relocate before starting work (Required)
Experience:
- Manufacturing Account Management: 3 years (Required)
Work Location: In person
About Viant
CEO: Alton Shader
Revenue: $500 million to $1 billion (USD)
Size: 5001 to 10000 Employees
Type: Company - Private
Website: www.viantmedical.com
Year Founded: 2007
