Quality Engineer

This is a fully remote position, open to applicants in New Hampshire.

📋 Description

• Conduct investigations into product, supplier, manufacturing, and quality system challenges while facilitating resolution efforts.

• Assist with CAPA initiatives, encompassing investigation, root cause analysis, action planning, implementation, effectiveness verification, and follow-up.

• Evaluate and review design, material, supplier, process, and documentation modifications for their potential impact on quality and regulatory compliance.

• Aid in risk management efforts, including the upkeep of risk management files and the evaluation of changes that could affect product risk.

• Collaborate with Engineering, Operations, and suppliers to devise compliant and practical solutions to quality-related challenges.

• Support supplier quality initiatives, involving issue investigations, corrective actions from suppliers, change assessments, and supplier communications.

• Engage in internal audits and assist with external audits and regulatory inspections.

• Contribute to the maintenance of the Quality Management System, which includes document control, training, quality metrics, audit preparedness, and continuous improvement efforts.

• Assess quality records, change orders, engineering documentation, and other quality system documents for completeness and compliance.

• Monitor quality actions and ensure commitments are fulfilled, documented, and maintained.

• Act as a quality resource for Engineering and other functional groups by offering guidance on quality system requirements, risk management, change control, investigations, and corrective actions.

• Facilitate the onboarding process for new suppliers and contract manufacturers as needed.

• Recognize opportunities to enhance quality system processes and overall operational efficiency.

⛳️ Requirements

• Bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical discipline.

• At least 5-8 years of experience in Quality Engineering, Quality Assurance, or Quality Systems within the medical device sector.

• Proficient understanding of FDA Quality System Regulation, ISO 13485, risk management principles, and medical device quality system standards.

• Experience in supporting investigations, CAPAs, supplier quality initiatives, and change management processes.

• Background in working cross-functionally with Engineering, Manufacturing, and Regulatory Affairs teams.

• Strong skills in technical problem-solving, communication, and organization.

• Capability to handle multiple projects and priorities in a dynamic environment.

• Outstanding communication and interpersonal skills.

🏝️ Benefits

• Comprehensive package beginning on Day 1, including medical, dental, vision, life insurance, and a 401(k) match.