Sr. Quality Engineer - Intellectt INC

Role : Sr. Quality Engineer

Location : Boston ,Ma

Duration: Long Term

Job Description:

We are seeking a Sr. Quality Engineer with extensive experience in the medical device industry to ensure product quality and regulatory compliance in a fast-paced, FDA-regulated environment. The ideal candidate will be responsible for developing and maintaining quality systems in alignment with ISO 13485, FDA 21 CFR Part 820, and other applicable standards. This role requires strong leadership, technical expertise, and a proactive approach to continuous improvement initiatives.

Key Responsibilities:

• Lead quality assurance activities for medical device products, ensuring compliance with FDA, ISO 13485, and GMP requirements.
• Oversee the development, implementation, and monitoring of CAPAs, root cause analysis, and risk management activities.
• Collaborate with cross-functional teams to ensure design, manufacturing, and testing processes meet quality standards.
• Conduct audits (internal, external, supplier) and ensure effective corrective actions are implemented.
• Provide technical support for non-conformance investigations, validations, and product release activities.

Required Skills:

• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and other medical device regulatory requirements.
• Experience with CAPA systems, root cause analysis, and risk management tools such as FMEA.
• Proficiency in data analysis and statistical process control (SPC).
• Excellent interpersonal and communication skills for cross-functional collaboration.
• Experience with supplier quality management and conducting audits.