ABOUT GENALYTE
At Genalyte were revolutionizing diagnostic testing to empower a healthier future. We believe that timely and accurate health insights shouldnt 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; Associates 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.
Required Experience:
Junior IC