Job Description
Job 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
PREFERRED QUALIFICATIONS:
• Experience working with semi-automated equipment
• Medical device manufacturing preferred • Knowledge of regulations (FDA, ISO, OSHA, etc.)
• Be able to prioritize and handle multiple tasks and responsibilities, attention to details
Company Description
Founded 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 race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other b
Company Description
Founded 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 race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other b