Job Summary
The Quality Assurance Coordinator is responsible for overseeing daily functions of the QA department, ensuring that all activities align with FDA regulations. This role involves conducting audits related to packaging and distribution materials to maintain high-quality standards. The Coordinator plays a key part in MDR project meetings, addresses nonconformance issues, and is responsible for training new staff to uphold compliance with established quality practices.
Responsibilities
- Oversee daily operations of the Quality Assurance department.
- Conduct audits of packaging and distribution materials in compliance with FDA regulations.
- Participate in MDR project meetings to provide quality assurance insights.
- Process and manage nonconformance reports effectively.
- Train and orient new employees on quality standards and procedures.
Qualifications
- A minimum of 3 years of relevant experience in a Quality Assurance role.
- High School Diploma or GED is required.
- Strong proficiency in statistical process control methodologies.
- Proficient in Microsoft Office applications.
- Ability to work onsite in Henrietta, NY.
CooperCompanies provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
