Incoming Quality Control (IQC) Specialist - Temp

ABOUT GENALYTE 

At Genalyte, we're revolutionizing diagnostic testing to empower a healthier future. We believe that timely and accurate health insights shouldn't be a luxury, but a necessity. We are driven by a vision where advanced diagnostic capabilities are accessible, efficient, and seamlessly integrated into healthcare. Genalyte is more than just a laboratory; we are advocates for health empowerment, dedicated to providing insights that can transform lives and communities.

POSITION SUMMARY
The Incoming Inspection Specialist will be responsible for performing detailed visual, dimensional, and documentation inspections of incoming materials, components, and finished products to ensure compliance with established quality standards, specifications, and regulatory requirements within a medical device manufacturing environment. This role is critical in maintaining the integrity and quality of our products from the initial stages of production. This is a temporary position with potential for permanent conversion.

ESSENTIAL FUNCTIONS & RESPONSIBILITIES

These may include but are not limited to: 

• Conduct thorough incoming inspections of raw materials, components, and sub-assemblies according to approved specifications, drawings, and procedures
• Verify documentation for accuracy and completeness, including Certificates of Analysis (COA), Certificates of Conformance (COC), and other relevant supplier documentation
• Perform dimensional measurements using precision measuring instruments (e.g., calipers, micrometers, gauges)
• Perform electronic measurements using a multimeter
• Conduct visual inspections for defects, damage, and non-conformities
• Identify and segregate non-conforming materials; initiate Non-Conformance Reports (NCRs) and assist in their investigation and resolution
• Maintain accurate and organized inspection records, logs, and databases
• Collaborate with purchasing, engineering, and quality assurance departments to resolve supplier quality issues
• Assist in the development and improvement of inspection procedures and work instructions
• Participate in internal and external audits as required
• Adhere to all safety regulations and company policies

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

• High school diploma or equivalent; Associate's degree in a technical field preferred
• 2+ years of experience in quality inspection, preferably within the medical device or other regulated industry
• Strong understanding of Good Manufacturing Practices (GMP) and relevant ISO standards (e.g., ISO 13485)
• Proficiency in reading and interpreting engineering drawings, blueprints, and specifications
• Demonstrated ability to use various inspection tools and equipment
• Excellent attention to detail and strong analytical skills
• Ability to identify and document non-conformances accurately
• Strong written and verbal communication skills
• Proficiency with  Google Workspace
• Ability to work independently and as part of a team

PHYSICAL REQUIREMENTS

• Ability to lift and move up to 25 pounds

• Ability to stand, walk, and sit for extended periods
• Good manual dexterity and visual acuity for detailed inspection tasks