Quality Assurance Manager

Job Description

Salary: $80,000.00 - $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.

· Author, revise, and maintain 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.

· 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