Job Summary:
As a Quality Control Inspector specializing in medical device components, incoming shipments, and raw materials, you will be responsible for ensuring that all incoming materials and components meet the necessary quality and regulatory standards. You will play a key role in maintaining the integrity of our supply chain and ensuring that only compliant materials are used in production.
Key Responsibilities:
Incoming Inspection:
o Inspect and test incoming raw materials, components, and shipments to verify they meet specified quality standards
and regulatory requirements.
o Utilize precision measurement tools and equipment to perform dimensional checks and functional tests.
o Review and verify accompanying documentation, such as certificates of analysis and compliance reports, for accuracy
and completeness.
Material Verification:
o Assess the quality of raw materials against established criteria and specifications to ensure they are suitable for
production use.
o Perform sampling and testing of materials in accordance with company procedures and regulatory standards.
o Report any non-conformance or deviations from quality standards to relevant stakeholders.
Documentation and Compliance:
o Maintain detailed records of inspections, tests, and outcomes, including non-conformance reports and corrective
actions.
o Ensure all inspection activities are documented accurately and comply with internal quality management systems and
external regulatory requirements (e.g., FDA, ISO).
o Assist in the development and maintenance of inspection protocols and quality control procedures for incoming
materials.
Supplier and Internal Collaboration:
o Work closely with suppliers to address quality issues, manage returns or rejections, and improve material quality.
o Collaborate with internal teams, including procurement, production, and engineering, to resolve quality-related issues
and implement improvements.
o Participate in supplier audits and assessments to ensure ongoing compliance with quality standards.
Problem-Solving:
o Investigate and analyze quality issues related to incoming materials and components to identify root causes and
implement corrective actions.
o Support the resolution of material-related quality concerns through effective communication and problem-solving
strategies.
Training and Support:
o Provide guidance and training to procurement and production staff on quality standards and inspection processes for
incoming materials.
Qualifications:
Education: High School Diploma or equivalent; Associate’s or Bachelor’s degree in a relevant field (e.g., Engineering,
Biomedical Science) is preferred.
Experience: Minimum of [2] years of experience in quality control or inspection, preferably in the medical device or
manufacturing industry.
Certifications: Certification in Quality Control (e.g., CQI, CQT) is advantageous.
Skills:
o Proficiency in using measurement tools and testing equipment specific to material inspection.
o Strong understanding of quality control principles and regulatory requirements for medical devices.
o Attention to detail and strong analytical skills.
o Effective communication and collaboration abilities.
o Ability to work independently and manage multiple tasks efficiently.
