Medical Device QC Inspector – Quality & Compliance

Amplitude Vascular Systems; Waltham (MA); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading medical device company seeks a Quality Control Inspector in Waltham, Massachusetts. The role involves performing inspections to ensure that products meet quality standards, collaborating with cross-functional teams, and adhering to strict regulatory compliance. Candidates should have over 3 years of experience in quality inspection within the medical device field, and a relevant degree or equivalent experience. This position requires strong attention to detail and proficiency in inspection tools.

Qualifications

• 3+ years of experience in quality inspection in the medical device industry.
• Strong understanding of quality systems and regulatory standards.
• Excellent attention to detail and documentation skills.

Responsibilities

• Perform incoming, in-process, and final inspections of components and finished products.
• Approve products by confirming specifications and conducting tests.
• Initiate non-conformance reports and ensure processing of non-conforming materials.

Skills

Quality inspection in medical device industry

Regulatory standards knowledge (ISO 13485, FDA 21 CFR Part 820)

Proficiency in inspection tools (calipers, micrometers)

Attention to detail

Cross-functional team collaboration

Problem-solving skills

Experience with electronic documentation systems

Knowledge of cleanroom protocols

Education

Associate or bachelor’s degree in business, supply chain, life sciences

Tools

Microsoft Office (Outlook, Excel, PowerPoint, Word)

Job description

A leading medical device company seeks a Quality Control Inspector in Waltham, Massachusetts. The role involves performing inspections to ensure that products meet quality standards, collaborating with cross-functional teams, and adhering to strict regulatory compliance. Candidates should have over 3 years of experience in quality inspection within the medical device field, and a relevant degree or equivalent experience. This position requires strong attention to detail and proficiency in inspection tools.