Job Description
Job Description
Job Description
Summary
Perform a wide variety of activities to support the Quality Management System.
Essential Duties and Responsibilities
Conduct product testing, including testing to support complaint investigations and stability verification
Generate product testing results reports
Review production batch records (DHR's) for accuracy and completeness in order to approve intermediate products for use in production. Review finished goods batch records. Report all deviations in these records and assures these have been addressed and resolved prior to issuing approval.
Conduct spot-checks inspections/audits of production operations
Participate in the internal audit program
Write, review and approve Standard Operating Procedures (SOPs) as necessary
May assist in supporting the Document Control program, record retention areas, and sample retention areas
May support returned instrument processing
Log returned instruments from the field.
Decontaminate returned instruments in a Biohazard level II environment following standard operating procedure and documenting decontamination as required.
Inspect returned instruments for damage, and performing basic investigation and documenting results prior to second level processing.
As necessary, process instrument documentation for return to repair facility, and pack instruments as required.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to follow Good
Manufacturing/Laboratory
Practices (GMP and GLP)
Education and/or Experience
Bachelor's degree in a scientific or technical area or equivalent combination of experience and education.
At least one year in quality assurance role in medical device industry is preferred.
Mathematical Skills
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Computer Skills
To perform this job successfully, an individual should have knowledge of Database software; Internet software; Inventory software; Spreadsheet software and Word Processing software.
Other Skills and Abilities
Ability to follow procedures and accurately document results
Understanding the manufacturing processes of Company products and ability to recognize deviations from approved documented procedures
Attention to detail.
Ability to use bleach for cleaning purposes is required.
\nCompany 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
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