Pay Rate Low: 20.00 | Pay Rate High: 26.00
Our client, a leading manufacturer in the medical device industry, is seeking a Quality Control Inspector II to support quality operations within a regulated manufacturing environment. This role is responsible for inspecting components, subassemblies, and finished products to ensure compliance with engineering drawings, specifications, inspection plans, and regulatory requirements. The ideal candidate has experience in FDA-regulated manufacturing and a strong understanding of quality inspection processes.
Location: Trumbull, CT
Schedule: 1st Shift | Monday-Friday | 8:00 AM - 4:30 PM EST
Pay: $20-$26/hour (depending on experience)
Employment Type: Contract-to-Hire
Key Responsibilities
- Perform routine and detailed inspections of incoming materials, in-process products, and finished goods.
- Conduct visual, dimensional, mechanical, and functional inspections using approved methods, tools, and measuring equipment.
- Verify compliance with engineering drawings, specifications, and inspection plans.
- Accurately document inspection results to maintain complete product traceability.
- Identify, document, and report defects or nonconforming materials (NCMRs).
- Provide guidance and support to less experienced quality inspectors.
- Assist Quality Management with product disposition decisions, including accept, reject, rework, or return to vendor.
- Collaborate with cross-functional teams to investigate and resolve quality issues.
- Support Corrective and Preventive Action (CAPA) activities.
- Participate in internal and external quality audits and regulatory inspections.
- Assist with additional quality initiatives and projects as assigned.
Qualifications
- Working knowledge of cGMP, FDA Quality System Regulations, and quality inspection practices within a regulated manufacturing environment.
- Familiarity with 21 CFR Part 820, ISO 13485, EU MDR, MDSAP, and other applicable quality standards.
- Ability to read and interpret engineering drawings, specifications, and inspection procedures.
- Proficiency using precision measuring instruments and inspection equipment.
- Experience with vision systems and automated inspection equipment preferred.
- Strong attention to detail and commitment to accuracy.
- Excellent organizational, troubleshooting, and problem-solving skills.
- Effective verbal and written communication skills.
- Proficient with Microsoft Excel, Word, Outlook, and PowerPoint.
Preferred Skills
- High School Diploma or GED required.
- Minimum 2 years of quality inspection experience within a medical device, healthcare manufacturing, or other FDA-regulated environment.
- ASQ Certified Quality Inspector (CQI) or Certified Quality Technician (CQT) certification is preferred.
- Production, clean room, warehouse, and office environment.
- Position requires extended periods of standing, sitting, walking, and frequent movement throughout the day.
- Must be able to occasionally lift up to 35 lbs.
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This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you**
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