What are the responsibilities and job description for the QC Associate position at System One?
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:
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.
- 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
