Genalyte, Inc.
Incoming Quality Control (IQC) Specialist - Temp
Genalyte, Inc., San Diego, California, United States, 92189
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
SALARY RANGE The base range for this role is $23 - $33 per hour. Individual pay may vary based on additional factors, including but not limited to, job-related skills, experience, work location, and relevant education or training.
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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
SALARY RANGE The base range for this role is $23 - $33 per hour. Individual pay may vary based on additional factors, including but not limited to, job-related skills, experience, work location, and relevant education or training.
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