Quality Engineer I

Quality Engineer I

The Associate Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk-based decisions, resolving and documenting customer complaint and manufacturing investigations, and representing Quality in cross-functional projects.

Job Duties

• Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
• Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness.
• Monitors and analyzes product performance of medical devices using a statistical and risk-based approach, considering any quality, compliance, customer, and business risks.
• Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation.
• Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization.
• Proficient in project management, data analysis, root cause analysis, communication, and risk determination.
• Ensures compliance with the client's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.

Top 3 Must-Have Skill Sets

• Cross-functional communication skills (will be working with all teams)
• Critical thinking (allows for quick on-the-spot thinking and ways to navigate unfamiliar issues)
• Prioritization (this position will pull you in all directions so knowing what is important is key)

Qualifications

• Years of experience required: 0-2 years of experience in Medical Device/Pharmaceutical regulated industry.
• Specific education requirements: Minimum - Bachelor's Degree with Engineering or Physical Science Coursework.
• Preferred - Bachelor's or Master's Degree in Engineering with 0-3 years' experience in Medical Device/Pharmaceutical regulated industry. ASQ Certification (e.g., CQA, CQE, CQM).