Quality Engineer

5 days ago

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RQM+

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Regulatory for Medical Device • Quality Systems for Medical Device • Design Assurance for Medical Device • Product Quality for Medical Device • Post-Market Surveillance for Medical Device

501 - 1000 employees

⚕️ Healthcare Insurance

🧬 Biotechnology

🤖 Artificial Intelligence

Description

• RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. • This role is responsible for developing, managing, and continuously evaluating policies, processes, and procedures to ensure the organization delivers compliant client services in alignment with ISO 9001 and any specific business unit standards. • The Quality Engineer will lead, coach, and teach RQM+ employees, promoting an understanding of quality system philosophies, methodologies, and expectations. • The role also drives continuous improvement within the quality management framework, identifying process enhancements and ensuring adherence to best practices, while fostering a culture of quality that meets client needs and regulatory requirements.

Requirements

• Bachelor’s degree in quality assurance, technical or related field. • Minimum 3-5 years of quality system experience in a regulated industry, medical device (preferred) or ISO 9001 environment. • Experience leading multiple projects in a fast-paced environment • Process Improvement experience preferred (Six Sigma, Lean or similar) • Certifications (preferred, but not required): Certified Quality Engineer (CQE) or other relevant quality certifications. • Strong analytical and problem-solving skills, with the ability to perform root cause analysis and drive continuous improvement. • Excellent communication skills, both written and verbal, with the ability to present complex quality issues clearly to cross-functional teams and management. • Proficient in the use of quality management software and tools • Strong attention to detail and a proactive approach to identifying and resolving quality issues. • Ability to coach, teach and lead others; work cross-functionally in a matrix organization • Ability to manage multiple projects and highly adaptable to business needs • Strong understanding of quality system management