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Quality Assurance Manager - Conshohocken, United States - Extremity Care
Description
Job DescriptionJob Description Salary:
$80, $85,000.00 per year
Purpose:
The Quality Assurance 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.
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).
Establish, evaluate, report, and provide improvements (where appropriate) for quality metrics.
Manage and oversee review of HCT/P donor records for final product release in accordance with standard operating procedures and
regulatory/accrediting
agency requirements.
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.
Review and approve
validation/verification
protocols, execution data, and summary reports.
Support internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, certification requirements, and internal policies and procedures.
Maintain professional working relationships with customers, partners, and vendors.Manage direct reports and monitor individual performance.
Maintain records in accordance with standard operating procedures.
Attend/participate in offsite business
meetings/conferences.
Establish and maintain KPIs, trends, and data for performance tracking of projects, processes, and team.
Drive initiatives for improving excellence in product quality and standards while ensuring regulatory compliance.
Perform other related duties as assigned.
Skills & Abilities:
Leadership & Management skills
Attention to detail
Organized
Verbal/Written Communication skills
Analytical Thinking skills
Technical Writing skills
Multi-tasking skills
Education & Experience:
Bachelor's degree in a 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
responsibility/experience
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