Purpose:

The Quality Control Manager is responsible for ensuring that all products and services meet established quality standards.

Duties & Responsibilities:

• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations (as appropriate), and industry standards
• Author and revise procedures/controlled documents according to FDA, AATB, and other applicable regulations
• Manage deviations, nonconformances, complaints, CAPAs, SCARs, and safety incidents and ensure timely completion of associated investigations
• Ensure adequacy of investigations with respect to root cause analysis and CAPA assessment (as appropriate)
• Manage and oversee incoming inspection of HCT/Ps and medical devices in accordance with standard operating procedures and regulatory/accrediting agency requirements
• Sort and segregate acceptable and unacceptable HCT/P products and/or medical devices
• Manage and oversee review of quality control records to include equipment cleaning, maintenance, environmental monitoring, and supply inspections
• Assist with training of processes and corrective actions relating to quality
• Support implementation of new projects/product development
• Support development of validation/qualification protocols and summary reports in accordance with regulatory requirements and industry best practices
• Support internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, certification requirements, and internal policies and procedures
• Manage direct reports and monitor individual performance
• Maintain records in accordance with standard operating procedures
• Recruit, interview, and hire personnel
• Perform other related duties as assigned
• Starting job duties on time
• Staying on the job throughout the assigned shift to complete duties properly
• Attending all scheduled meetings and appointments.

Skills & Abilities:

• Experience in Leadership & Management
• Excellent attention to detail and organizational skills
• Verbal and written communication skills
• Analytical Thinking and Technical Skills
• Multi-Tasking
• Ability to secure and maintain a favorable background investigation and clearance.

Education & Experience:

• Bachelor’s degree in Biological Scient or related field required
• At least 5 years of experience in quality in an FDA regulated environment for HCT/Ps and/or medical devices (or related field), with progressive management responsibilities/experience