VERO Biotech · 10 hours ago
Quality Engineer
Atlanta, GA
Full-time
Onsite
Mid, Senior Level
4+ years expVERO Biotech is dedicated to improving the lives of patients through innovative technologies in critical care and respiratory therapy. The Design Quality Engineer (DQE) will lead quality initiatives for New Product Development, ensuring compliance with regulatory standards and guiding cross-functional teams throughout the design and development process.
BiotechnologyMedical DeviceHealthcarePharmaceuticalHealth CareHealth DiagnosticsMedical
Responsibilities
Serve as the primary Quality representative on cross-functional project teams, guiding R&D through the Design Control process (Design Planning, Inputs, Outputs, and Reviews)
Oversee and approve Design Verification and Design Validation (V&V) activities, ensuring protocols and reports are statistically valid and meet user needs
Lead the transition of products from R&D to manufacturing, ensuring that the Device Master Record (DMR) is complete and production processes are validated (IQ/OQ/PQ)
Support Human Factors and Usability studies in accordance with IEC 62366 to ensure the device is safe for the intended user
Lead the Risk Management process per ISO 14971, maintaining Risk Management Files (RMF) including Hazard Analysis, DFMEA, and PFMEA
Ensure a closed-loop link between clinical risk assessments, design mitigations, and manufacturing controls
Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR 2017/745
Provide guidance on IEC 62304 lifecycle requirements and software validation (CSV) for devices containing software (SiMD) or standalone software (SaMD)
Ensure all documentation adheres to Good Documentation Practices (GDP) and 21 CFR Part 11
Participate in supplier audits and assessments to ensure components meet critical-to-quality (CTQ) specifications
Lead investigations into design-related non-conformances (NC) and implement Corrective and Preventive Actions (CAPA) to prevent recurrence
Apply statistical techniques (e.g., Gage R&R, SPC, DOE) to characterize processes and set rational sample sizes for testing
Qualification
Required
Bachelor's Degree (BS) in Engineering (Mechanical, Biomedical, Electrical) or a related scientific field
Minimum of 4 years of experience in a regulated medical device or biotechnology environment
Minimum of 7 years of experience, with a proven track record of leading at least one full product launch (concept to commercialization)
Expert-level understanding of ISO 13485 and ISO 14971
Working knowledge of IEC 62304 and software validation principles
Proficiency in Minitab or similar statistical software; advanced proficiency in Microsoft Office
Ability to synthesize complex technical data into clear risk-based decisions
Ability to influence cross-functional teams and challenge design assumptions constructively
Comfortable working in an agile R&D environment with changing priorities
Ability to sit or stand for extended periods; manual dexterity to handle small medical device components
Preferred
ASQ Certified Quality Engineer (CQE) or Certified Biomedical Auditor (CBA) is highly preferred
Company
VERO Biotech
Vero Biotech is a biopharmaceutical company that commercializes inhaled nitric oxide delivery systems for healthcare providers.
201-500 employees
H1B Sponsorship
VERO Biotech 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
2021 (2)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$234.64MKey Investors
Petrichor Healthcare Capital ManagementMVM Life Science PartnersRunway Growth Capital
2023-01-11Series Unknown· $30M
2021-12-21Series E· $100M
2021-01-20Debt Financing· $50M
Leadership Team
Brent V. Furse
Chief Executive Officer & President
Roberto Cohen
Chief Financial Officer
Recent News
GlobeNewswire News Room
2025-02-20
Company data provided by crunchbase