Quality Control Inspector

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

Join our dynamic R&D team as a Quality Control Inspector. In this role, you’ll play a critical role in ensuring that our Pulse IVL System product meets established quality standards and specifications at various points in the organization while advocating for strict adherence to compliance practices within the facility.

Key Responsibilities

• With minimal supervision, performs incoming, in-process, and final inspections of components and finished device.
• Interprets quality inspection documents and deciphers quality expectations for the product.
• Approves products by confirming specifications, conducting visual and measurement tests, returning products for re-work and confirming re-work
• Monitors use of equipment to ensure it is calibrated before use; keeps measurement equipment operating accurately
• Performs and documents results of inspections per company procedures.
• Responsible for initiating non-conformance reports and ensuring non-conforming material is processed in accordance with the disposition. May assist with nonconformance investigations as needed.
• Review and verify documentation for compliance with specifications and regulatory requirements (e.g., FDA, ISO 13485).
• Maintain accurate inspection records and support traceability and documentation control.
• Collaborate with engineering and manufacturing teams to identify and resolve quality issues.
• Assist in root cause analysis and corrective/preventive actions (CAPA).
• Support internal audits and regulatory inspections.
• Ensure calibration and maintenance of inspection tools and equipment.

Required Qualifications

• Associate or bachelor’s degree in business, supply chain, life sciences or other scientific field or equivalent work experience (3-5 years).
• 3+ years of experience in quality inspection in the medical device industry.
• Strong understanding of quality systems and regulatory standards (ISO 13485, FDA 21 CFR Part 820).
• Proficiency in using inspection tools (calipers, micrometers, gauges, vision systems) and reading technical drawings/specifications.
• Excellent attention to detail and documentation skills.
• Ability to work independently and as part of a cross-functional team.
• Strong communication and problem-solving skills.
• Experience with electronic documentation systems (e.g., eQMS).
• Familiarity with cleanroom protocols and GMP practices.
• ASQ certification (e.g., CQI) is a plus.
• Two (2) or more years of laboratory experience
• Experience in QC inspection, cleanroom manufacturing, and medical device start-up
• 3+ year of Quality Control Experience in Medical Device Manufacturing. Knowledge of clean room operations
• Understanding of a quality management system (QMS) and cGMP knowledge
• Proficient level with Microsoft Office (Outlook, Excel, PowerPoint, and Word)
• Knowledge of Non-Conformance Reports (NCRs)