Quality Specialist

Hunter Recruiting; Somerville (NJ); On-site; USD 75,000 - 105,000; Full time

Job summary

Hunter Recruiting is seeking a Quality Specialist to support and maintain the Quality Management System for medical device, pharma and combination device sterilization operations. The role focuses on change control, SOP updates, training, supplier approvals and incoming inspection to ensure regulatory compliance.

The ideal candidate has a Bachelor's degree in a scientific discipline and 3–7 years of GMP quality experience, with CFR 210/211 and knowledge of cGMP, QMSR, ISO 13485 and ISO 14971.

Qualifications

• 3–7 years of quality experience in a GMP regulated industry.
• Experience with CFR 210 and CFR 211.
• Knowledge of cGMP, QMSR, ISO 13485 and ISO 14971.

Responsibilities

• Manage the change control process including creating the ECO documentation, SOP redlines, SOP updates, SOP creation and approval.
• Ensure 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.

Skills

Quality experience

Regulatory knowledge

Time management

Interpersonal skills

Education

Bachelor's degree in science

Tools

Change control

Job description

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.

Responsibilities

• Manage the change control process including creating the ECO documentation, SOP redlines, SOP updates, SOP creation and approval.
• Ensure 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.

Qualifications

• Bachelor's degree in a scientific discipline or equivalent experience.
• 3–7 years of Quality experience in a GMP regulated industry, preferably contract sterilization.
• Experience with CFR 210 and CFR 211.
• 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.