QC Associate - System One
Jersey City, NJ
About the Job
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
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Source : System One