Rook Quality Systems ยท 2 months ago
Quality Engineer Medical Device
Atlanta, GA
Full-time
Onsite
Entry, Mid Level
$70K/yr - $90K/yr
1+ years expRook Quality Systems is a consulting firm experiencing rapid growth, seeking quality engineers to support their medical device clients. The role involves providing quality engineering support for the design, risk analysis, and verification/validation of new medical device products, while ensuring compliance with relevant standards and regulations.
AdviceConsultingMedical Device
Responsibilities
Work as a quality consultant for medical device companies and various types of devices, diagnostics, and SaMD
Provide Quality Engineering support of for the design, risk analysis, and verification/validation of new medical device products
Work closely with startup medical device companies and products to ensure all aspects of the design history file, technical file, and risk management file are completed during the development process
Assist product development teams during development of new devices and software. Responsible for implementation of product quality plans, verification/validation protocols and reports
Maintain quality system processes and procedures to ensure compliance to all domestic and international standards or requirements. Keep current on all applicable best practices and statutory regulations governing the design, procurement, manufacture, marketing, and distribution of medical devices
Conduct and support internal and external audits for clients to maintain compliance with the FDA, ISO 13485, CE Mark (MDR), MDSAP
Support post-market activities including CAPA, non-conformances, complaint handling and investigation, supplier assessment, adverse event reporting, and other activities
Qualification
Required
Bachelor's degree or equivalent in Engineering or related field
1-5+ years' of industry experience
Strong knowledge of quality tools used in the industry
Analytical and quantitative approach to problem solving
Strong communications skills
Benefits
Collaborative team dedicated to working to support medical device innovation and compliance.
Remote working and flexible hours
PTO
Health and Dental Insurance
401k
Employee training and certifications provided
Company
Rook Quality Systems
Rook Quality Systems specializes in quality and regulatory strategies consulting for medical device companies.
11-50 employees
H1B Sponsorship
Rook Quality Systems has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
2021 (2)
2020 (1)
Funding
Current Stage
Early StageLeadership Team
Andrew Wu
General Manager
Recent News
Company data provided by crunchbase