Senior Quality Engineer: Med Device ISO 13485 Expert

Smc; Ayer (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical supplier in Massachusetts is seeking a Quality Engineer with extensive experience in the healthcare industry. The ideal candidate will manage quality projects and compliance, engage in product handling from receiving to shipping, and ensure adherence to ISO 13485 regulations. Responsibilities include leading investigations, creating documentation, and training personnel. The role demands strong problem-solving skills, attention to detail, and effective communication abilities, making it ideal for dedicated professionals seeking impactful work in a growing organization.

Qualifications

• 5-7 years of experience as a Quality Engineer in the healthcare industry.
• Experience with ISO 13485 and 21 CFR Part 820 Quality System Regulation.
• Ability to read and understand detailed part/article drawings.

Responsibilities

• Manage activities for handling healthcare products from receiving to shipping.
• Lead customer complaint and CAPA investigations.
• Create and maintain quality system documentation.

Skills

Problem solving

Interpersonal skills

Leadership

Technical writing

Education

Bachelor of Science Degree

Tools

ISO 13485

Quality inspection equipment

Job description

A leading medical supplier in Massachusetts is seeking a Quality Engineer with extensive experience in the healthcare industry. The ideal candidate will manage quality projects and compliance, engage in product handling from receiving to shipping, and ensure adherence to ISO 13485 regulations. Responsibilities include leading investigations, creating documentation, and training personnel. The role demands strong problem-solving skills, attention to detail, and effective communication abilities, making it ideal for dedicated professionals seeking impactful work in a growing organization.