[Hiring] Sr. Quality Engineer @E2HELO

Role Description

The Staff Quality Engineer is responsible for providing quality engineering direction to projects, such as:

• Risk management
• Design concepts
• Design specifications
• Design for quality and manufacturing requirements
• Process/technology development
• Design and process validation
• Measurement systems analysis
• Equipment and software validation
• Project planning
• Associated documentation

This position will play an active role in developing the quality management system and ensuring QMS compliance adherence.

Qualifications

• Minimum 5 years relevant experience in the medical device industry.
• Experience in Quality System requirements, such as:
  • Design Control
  • Risk Management
  • Quality
  • Production Process Controls
  • Supplier Controls
  • Corrective and Preventive Action
  • Non-Conformance
  • Complaint Management
  • Post Market Surveillance
• Bachelor's Degree in Life Sciences, Engineering, or equivalent is preferred.
• Biomedical or Quality Auditor certification desired.

Requirements

• Develop, establish, and maintain QA processes, procedures, and controls ensuring that performance and quality of products conform to established standards and regulations.
• Work with R&D, Manufacturing Engineering, Regulatory, and Clinical team to develop and execute Quality Engineering activities to meet project milestones.
• Provide guidance and oversee the documentation process (Design History File, Device History Records and Device Master Records).
• Participate in designing and drafting plans/protocols for testing of complex medical device products with the Quality and R&D team.
• Lead Risk Management efforts in accordance with ISO 14971 and Design Control efforts in accordance with ISO 13485 and 21CFR 820.
• Participate on Corrective and Preventive Action teams in response to concerns identified through complaints, nonconforming materials or other trending activities.
• Qualify new suppliers, maintain the Approved Supplier List (ASL), and manage the Supplier Corrective Action Request (SCAR) program.
• Participate in Quality Assurance audits from 3rd party agencies, ensure timely and effective resolution of issues identified.
• Maintain quality system in compliance with all applicable regulatory standards (FDA QMSR, ISO 13485, MDR requirements) and other relevant requirements throughout the facility.
• Identify and implement changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system using: quality policy, quality objectives, audit results, analysis of data, etc.
• Other duties as assigned.

Company Description