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 play a crucial part in ensuring the quality and compliance of medical devices. You will collaborate with cross-functional teams to uphold the highest standards in design history files and regulatory requirements.
What You'll Do
- Conduct thorough quality assurance assessments on medical devices to ensure compliance with ISO 13485 and FDA regulations.
- Review and maintain design history files, ensuring all documentation meets regulatory standards.
- Collaborate with design and development teams to implement effective design controls and risk management strategies.
- Participate in internal audits and assist in the preparation of regulatory submissions.
- Utilize software testing tools, including Postman, to validate system functionality and performance.
- Provide training and support to team members on quality assurance processes and documentation standards.
- Continuously monitor and improve quality assurance processes to enhance efficiency and effectiveness.
Requirements
- 3-5 years of experience in quality assurance within the medical device industry.
- Strong knowledge of ISO 13485, FDA Quality System Regulations, and risk management principles.
- Experience with documentation review and regulatory compliance.
- Proficiency in Microsoft Word and software testing tools.
- Excellent attention to detail and strong analytical skills.
Nice to Have
- Experience with test automation tools.
- Familiarity with clinical trials and healthcare billing processes.
- Certification in quality assurance or regulatory affairs.
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 drive quality improvements.
- Professional development and training opportunities to enhance your skills.
- Competitive salary and benefits package.
This remote Quality Design Assurance Specialist role offers a competitive salary and the chance to work in the healthcare industry, ensuring compliance with medical device regulations.
Who Will Succeed Here
Proficient in ISO 13485 and FDA regulations, with hands-on experience conducting quality assurance assessments specific to medical devices, ensuring compliance and safety standards are met.
Self-motivated and detail-oriented, thriving in a remote work environment, able to manage time effectively while collaborating with cross-functional teams to enhance quality assurance processes.
Analytical mindset with a strong understanding of risk management and software testing methodologies, utilizing tools like Postman for API testing and documentation review to ensure product quality.
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