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Quality Specialist
Somerville, NJ
Competitive Pay & Benefits
The Quality Specialist is responsible for supporting and maintaining the Quality Management System (QMS) for medical device, pharma and combination device sterilization operations. This role is responsible for managing the change control process, creating and updating standard operating procedures, managing the training, approved supplier list and incoming inspection processes while maintaining regulatory compliance.
Quality Specialist Responsibilities:
Quality Specialist Requirements:
Hunter International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, and gender expression), national origin, age, disability, genetic information, veteran status, or any other status protected by applicable federal, state, or local law. We comply with all applicable equal employment opportunity and affirmative action regulations.
Somerville, NJ
Competitive Pay & Benefits
The Quality Specialist is responsible for supporting and maintaining the Quality Management System (QMS) for medical device, pharma and combination device sterilization operations. This role is responsible for managing the change control process, creating and updating standard operating procedures, managing the training, approved supplier list and incoming inspection processes while maintaining regulatory compliance.
Quality Specialist Responsibilities:
- Manage the change control process including creating the ECO documentation, SOP redlines, SOP updates, SOP creation and approval.
- Ensures project work meets the applicable regulatory standards, customer specifications and applicable FDA regulations (QMSR, CFR 210 and CFR 211, ISO 13485 and ISO 14971).
- Manage the company wide training program.
- Certify and recertify the employees with the company quality policies and procedures.
- Manage the approved supplier list and company distribution.
- Manage the incoming inspection process.
- Achieve established productivity and quality performance goals while supporting operational excellence.
- Adhere to all safety rules, quality standards, and company policies and procedures.
- Perform all assigned tasks in a safe, efficient and productive manner.
- Execute additional responsibilities, as assigned to support departmental and organizational objectives.
Quality Specialist Requirements:
- Bachelor's degree in a scientific discipline or equivalent experience.
- 3–7 years of Quality experience in a GMP regulated industry, preferably contract sterilization.
- Extensive working knowledge of cGMP, QMSR, ISO 13485 and ISO 14971 requirements.
- High level of professionalism with excellent interpersonal and customer service skills.
- Exceptional time management abilities with proven success managing multiple priorities simultaneously.
#INDHS
Hunter International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, and gender expression), national origin, age, disability, genetic information, veteran status, or any other status protected by applicable federal, state, or local law. We comply with all applicable equal employment opportunity and affirmative action regulations.
