QUALITY ASSURANCE ASSOCIATE/ Medical Device
On-site · Philadelphia, Pennsylvania, United States
Job Summary
The Quality Assurance Associate will be responsible for writing and reviewing SOPs, maintaining control documents, and ensuring GMP compliance through audits and validations. The role requires performing investigations on non-conformances, supporting clients with GCP/QA advice, and assisting in the maintenance of the Quality Management System. Applicants should have a Bachelor's Degree, 4-6 years of relevant experience, strong communication skills, and proficiency in MS Office. Experience in a regulated medical device environment and familiarity with ISO13485 and related regulations is essential.
Required Qualifications
- Bachelors's Degree in related field
- 4-6 years related experience
- Experience working in regulated environment with medical devices
- Exceptional oral and written communication capabilities
- Advance computer knowledge in MS Office programs
Desired Qualifications
- Experience with FDA inspections and /or Notified Bodies Audits desirable
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