Quality Engineer

Description

Our Mission:
At VERO Biotech, our mission is to improve the lives of patients by developing innovative technologies that support critical care and respiratory therapy through inhaled nitric oxide delivery in the acute care hospital setting or wherever nitric oxide treatment is needed.

We strive to exceed customer expectations in terms of safety, efficacy, and value by focusing on the science, development, and commercialization of our innovations.

We kindly request that recruiting agencies or third‑party recruiters do not contact us regarding this position.

The Design Quality Engineer (DQE) serves as the quality lead for New Product Development (NPD) and product lifecycle management. This role is responsible for ensuring that medical devices/combo products are designed and developed in full compliance with the Quality Management System (QMS), ISO 13485, cGMP, FDA (ie. 21 CFR part 11, 21 CFR part 210/211, 21 CFR part 820) and other relevant regulations and industry standards.

The DQE acts as a strategic partner to R&D, ensuring that "Quality by Design" is integrated from initial concept through design transfer and into commercialization. ISO 13485, cGMP, FDA (ie. 21 CFR part 11, 21 CFR part 210/211, 21 CFR part 820) and other relevant regulations and industry standards

• Quality Lead:
  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).
• Verification & Validation:
  Oversee and approve Design Verification and Design Validation (V&V) activities, ensuring protocols and reports are statistically valid and meet user needs.
• Design Transfer:
  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).
• Usability Engineering:
  Support Human Factors and Usability studies in accordance with IEC 62366 to ensure the device is safe for the intended user.

• Risk Lifecycle:
  Lead the Risk Management process per ISO 14971, maintaining Risk Management Files (RMF) including Hazard Analysis, DFMEA, and PFMEA.
• Clinical Alignment:
  Ensure a closed-loop link between clinical risk assessments, design mitigations, and manufacturing controls.

• Regulatory Standards:
  Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR 2017/745.
• Software Quality:
  For devices containing software (SiMD) or standalone software (SaMD), provide guidance on IEC 62304 lifecycle requirements and software validation (CSV).
• Data Integrity:
  Ensure all documentation adheres to Good Documentation Practices (GDP) and 21 CFR Part 11.

• Supplier
  
  Qualification:
  
  Participate in supplier audits and assessments to ensure components meet critical-to-quality (CTQ) specifications.
• Root Cause Analysis:
  Lead investigations into design-related non-conformances (NC) and implement Corrective and Preventive Actions (CAPA) to prevent recurrence.
• Statistical Analysis:
  Apply statistical techniques (e.g., Gage R&R, SPC, DOE) to characterize processes and set rational sample sizes for testing.

• Education:
  
  Bachelor’s Degree (BS) in Engineering (Mechanical, Biomedical, Electrical) or a related scientific field.
• Quality Engineer:
  Minimum of 4 years of experience in a regulated medical device or biotechnology environment.
• Sr. Quality Engineer:
  Minimum of 7 years of experience, with a proven track record of leading at least one full product launch (concept to commercialization).

• Standards:
  Expert-level understanding of ISO 13485 and ISO 14971.
• Software:
  Working knowledge of IEC 62304 and software validation principles.
• Tools:
  Proficiency in Minitab or similar statistical software; advanced proficiency in Microsoft Office.
• Certifications:
  
  ASQ Certified Quality Engineer (CQE) or Certified Biomedical Auditor (CBA) is highly preferred.

• Analytical Thinking:
  Ability to synthesize complex technical data into clear risk-based decisions.
• Collaborative Leadership:
  Ability to influence cross-functional teams and challenge design assumptions constructively.
• Adaptability:
  Comfortable working in an agile R&D environment with changing priorities.

• Environment:
  Standard office and laboratory setting.
• Physical:
  Ability to sit or stand for extended periods; manual dexterity to handle small medical device components.