Associate Quality Engineer

HonorVet Technologies (SDVOSB) provides specialized and scalable staffing solutions to pharmaceutical companies, medical device companies, biotech organizations, CROs, research laboratories, and life sciences organizations across the United States. With strong delivery capabilities and rapid turnaround times, we support contract, direct hire, project-based, and consulting staffing needs across clinical research, pharmacovigilance, regulatory affairs, quality assurance, quality control, medical affairs, manufacturing, validation, and scientific operations. Our dedicated recruitment team focuses on delivering qualified life sciences and pharmaceutical professionals efficiently while ensuring quality, compliance, and client satisfaction.

• 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.

• 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 analyses product performance of medical devices using a statistical and risk-based approach. Considers 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
• Ensure compliance with the company'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.

• 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)

• 0-2 years of experience in Medical Device /Pharmaceutical regulated industry.

• 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)