Quality Engineer

The Quality Engineer is an entry-level position responsible for ensuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and external experts to implement Quality goals.

Responsibilities:

• Partner with design and cross-functional development teams to support software quality activities for new product introductions.
• Contribute to software architecture, design, implementation, integration, and maintenance activities for product development projects under the guidance of more senior engineers.
• Maintain software design and quality documentation and help ensure it remains current throughout the product lifecycle.
• Support software changes, enhancements, defect corrections, and sustaining engineering activities for released products. Assist with software risk management activities, including hazard analysis, risk assessments, and implementation of risk controls.
• Support verification and validation planning, protocol development, execution, and documentation.
• Participate in design reviews and provide input to help ensure robust, compliant, and maintainable software solutions.
• Collaborate with quality, regulatory, systems, and test engineering teams to support compliance with internal procedures and external standards.
• Review technical documentation, including software requirements, architecture and design documents, test protocols, traceability matrices, and change records, with support from senior team members as needed.
• Help ensure software development activities align with design controls, software development lifecycle processes, and applicable regulatory expectations.
• Support troubleshooting, root cause investigations, and continuous improvement initiatives.
• Learn from senior engineers and contribute across projects and product platforms as a developing quality engineering professional.
• Support audit, inspection, and regulatory submission readiness activities as needed.

Requirements:

• Bachelor's degree and at least 1 year of related experience.
• Familiarity with 21 CFR 820/ISO13485/IEC 62304 and other government/ISO standards preferred.
• Experience in regulated industries.
• Medical device experience preferred.
• Strong computer skills (MS Office Suite and Adobe).