Quality Control Inspector

Job DescriptionJob Description

RESPONSIBILITIES:
• Perform and document incoming, in-process, and final QC testing of in-vitro diagnostics devices to meet compliancy requirements including ISO, FDA
and international regulations
• Familiarity with all aspects of product and be able to identify defects
• Cross-train on all processes in QC lab
• May train new staff on processes
• Able to solve process-related questions/problems
• Use Agile to issue quality incidence; perform root cause investigation and write investigation report
• Perform validation study or other appropriate analyses for current or new product/ new features of the product
• Prepare adulteration controls and DOA controls as needed
• Be able to use analytical balance, optical comparator, vacuum chamber, caliper, gauges and the other tools to perform QC testing or measurements
• Ensure timely release of product
• Ensure cleanliness of the QC lab
• Assist the head of QC department with any necessary tasks
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships
• Carries out duties in compliance with established business policies
• Other duties as assigned, according to the changing needs of the business

MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:
• Requires high school diploma
• Two to five years of laboratory experience
• Ability to follow detailed instructions, maintains accurate records and notes, and carry out assignments in a thorough, conscientious fashion while adhering to safe laboratory practices
• Good written and verbal communication skills
• Experience working in GMP environment
• Intermediate knowledge of a variety of lab equipment and their operation
• Intermediate knowledge of MS Office and manufacturing systems

QUALIFICATIONS:
• Experience working with semi-automated equipment
• Medical device manufacturing
• Knowledge of regulations (FDA, ISO, OSHA, etc.)
• Be able to prioritize and handle multiple tasks and responsibilities, attention to details

Company DescriptionFounded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.

At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.

Kyyba is an Equal Opportunity Employer.

Kyyba does not discriminate on the basis of , , , sex, , , , non-disqualifying physical or mental , , veteran status or any other bCompany DescriptionFounded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.\r\n\r\nAt Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.\r\n\r\nKyyba is an Equal Opportunity Employer.\r\n\r\nKyyba does not discriminate on the basis of , , , sex, , , , non-disqualifying physical or mental , , veteran status or any other b