Quality Design Assurance Specialist - Remote
About the Role
We are seeking a dedicated Quality Design Assurance Specialist - Remote to join our team. In this role, you will be instrumental in ensuring that our medical devices meet the highest quality standards. You will collaborate with cross-functional teams to maintain compliance with regulatory requirements and contribute to the development of design history files.
What You'll Do
- Conduct thorough documentation reviews to ensure compliance with ISO 13485 and FDA regulations.
- Participate in internal audits and risk management assessments to uphold quality standards.
- Collaborate with design and development teams to implement quality assurance processes.
- Utilize software testing methodologies and tools, including test automation and Postman, to validate product functionality.
- Provide hands-on support in quality assurance for medical device projects, ensuring adherence to design control processes.
Requirements
- 3-5 years of experience in quality assurance, particularly in the medical device industry.
- Strong understanding of regulatory compliance, including ISO 13485 and FDA Quality System Regulations.
- Proficiency in documentation management and review processes.
- Experience with software testing and automation tools.
- Excellent attention to detail and strong analytical skills.
Nice to Have
- Familiarity with clinical trials and billing processes.
- Experience in cross-functional team collaboration.
- Certification in quality assurance or related fields.
What We Offer
- Opportunity to work in a remote environment with flexible hours.
- Hands-on experience with quality assurance in medical devices.
- Collaboration with cross-functional teams to enhance your professional skills.
- Professional development and training opportunities to advance your career.
- Competitive salary and benefits package.
This remote Quality Design Assurance Specialist role offers a chance to work in the medical device industry, ensuring compliance and quality standards while enjoying professional development opportunities.
Who Will Succeed Here
Proficient in test automation tools such as Selenium or TestComplete, with a solid understanding of software testing methodologies to ensure robust quality assurance processes.
Detail-oriented mindset with experience in documentation review, specifically in the context of ISO 13485 and FDA regulations, to ensure compliance and thoroughness in quality management.
Self-motivated and disciplined to thrive in a remote work environment, demonstrating strong organizational skills and the ability to manage multiple projects independently while collaborating with cross-functional teams.
Learning Resources
Career Path
Market Overview
Skills & Requirements
Domain Trends
Industry News
Loading latest industry news...
Finding relevant articles from the last 6 months