QA Specialist
Job Location:
Santa Clara County, CA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Job Title: Quality Assurance Specialist (QA Specialist)
Location: Santa Clara CA
Duration: 6 Months
Industry: Medical Device (Preferred)
Experience: 24 Years
Job Summary
We are looking for a Quality Assurance Specialist with 24 years of experience to support quality system activities and maintain Design History Files (DHF) documentation. The ideal candidate will have experience in a regulated environment and a basic understanding of design controls and quality processes.
Responsibilities
- Maintain and review Design History Files (DHF) and quality documentation.
- Support document control and change control activities.
- Assist with CAPA nonconformance and quality investigations.
- Review records to ensure compliance with company procedures and regulatory requirements.
- Support internal audits and quality system improvements.
- Collaborate with Engineering Manufacturing and Regulatory teams.
Requirements
- Bachelors degree in Engineering Life Sciences or a related field.
- 24 years of Quality Assurance experience in a regulated industry.
- Experience working with DHFs and design control documentation.
- Knowledge of FDA regulations ISO 13485 and Good Documentation Practices.
- Strong attention to detail and organizational skills.
- Good written and verbal communication skills.
Preferred:
- Medical device industry experience.
- Exposure to CAPA change control and risk management activities.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
About Company
At Fusion Plus Solutions Inc, we believe that it’s an exceptional company - a company of people proud of the work they do and the solutions they provide. By understanding what drives our specialty industries, becoming involved in our communities on a professional and personal basis, f ... View more
