What are the responsibilities and job description for the Quality Control Manager position at Extremity Care?
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 Science 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
