QC Associate

3 weeks ago


Jersey City, United States Disability Solutions Full time

Job Title: QC Associate
Location: Jersey City, NJ
Type: Direct Hire
Hours: Monday-Friday 9AM-5PM

Job Summary:
Our company is recognized as a certified global leader in medical biotechnologies, specializing in tissue engineering. We are looking for a talented and competitive Quality Compliance Associate who thrives in the medical device industry.

Responsibilities: Initiating and/or managing non-conformities / CAPAs (Corrective Actions/Preventive Actions) and change management forms.
Management of distributor and supplier qualifications.
Maintain QMS compliant with FDA, ISO13485, and MDSAP requirements.
Evaluate performance of QMS.
Support R&D Team in design controls records.
Supervise internal audit process.
Coordinating, monitoring, and managing of quality functions across multiple departments to ensure high level of compliance with industry quality standards.
Other duties related to the Quality Management System.

Requirements: Bachelor’s in biology or related field
Minimum 5 years’ experience in the medical device or pharmaceutical industry
Good organizational skills
Verbal and written communication skills


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