QUALITY ENGINEER – BOCA RATON, FL - $90k - $110k

Founded in 2020, this innovative company is dedicated to revolutionizing cancer treatment through cutting-edge oncology products and solutions. Their mission is to empower researchers, clinicians, patients, and their families worldwide in the fight against cancer.

Position Overview:

My client is seeking a dedicated Quality Engineer to join their dynamic team. The ideal candidate will be responsible for developing, implementing, maintaining, and improving quality assurance processes to ensure our products meet the highest standards of safety and efficacy.

Key Responsibilities:

• Quality Management System (QMS): Develop, implement, and maintain a comprehensive QMS in accordance with ISO 13485 standards.
• Process Design and Implementation: Design and implement procedures and processes for managing quality throughout the product lifecycle.
• Quality Reporting: Develop, execute, and analyze quality reporting measures to monitor key performance indicators and identify areas for improvement.
• Audits: Lead and coordinate internal audits to assess adherence to ISO requirements and support external audits by regulatory agencies and customers.
• Risk Management: Conduct risk assessments, establish quality objectives, and perform root cause analyses to develop corrective action plans.
• Collaboration: Work closely with cross-functional teams, including production, engineering, and regulatory affairs, to resolve quality issues and drive continuous improvement initiatives.

Qualifications:

• Education: Bachelor's degree in mechanical, Electrical, or Manufacturing Engineering, or a related field.
• Experience: 2+ years of experience in the medical device industry, with a focus on quality engineering and familiarity with ISO 13485 standards.
• Technical Skills: Strong knowledge of quality tools and methodologies, including statistical process control, root cause analysis, and risk management.
• Regulatory Knowledge: Familiarity with FDA regulations and GMP guidelines is preferred.
• Soft Skills: Excellent analytical, problem-solving, and communication skills. Ability to work effectively both independently and as part of a team in a dynamic, startup environment.

Benefits:

• Unlimited PTO
• Flexible work schedule
• Opportunity to work closely with world-class scientists and industry leaders
• Health, Dental, and Vision Insurance