Quality Systems Manager

Responsibilities

• Oversees critical Quality Systems programs to ensure compliance with applicable regulations, standards and company objectives including: Complaint Handling and Post-Market Surveillance activities; Internal and third-party audits; Maintenance of quality and regulatory registrations, licenses, accreditations, and certifications, including notifications; Document Management and Record Control; Non-conformance (NC) and Corrective Action/Preventive Action (CA/PA); Change Management
• Collects, analyzes, and reports data elements to demonstrate conformity and maintain effectiveness of the quality management system
• Supports and provides guidance to stakeholders in execution of NC, CA/PA, and audit response actions
• Manages staff members in leading and participating in third-party audits including Notified Body inspections, leads cross-functional teams to support the development of responses, and tracks response commitments within the CA/PA system
• Develops and implements process improvement initiatives within Quality Systems programs to increase efficiency and reduce complexity
• Supports company process improvement initiatives that impact Quality Systems and works collaboratively with cross-functional stakeholders to ensure compliance of processes and procedures within the quality management system
• Reviews and approves quality system documentation for accuracy, consistency and compliance
• Leads the Quality System team by recruiting, onboarding, training, developing career growth opportunities, and giving effective performance feedback
• Other duties as assigned

Requirements

Education: Bachelor’s degree in a life sciences discipline or related field

Experience: 5+ years of experience in a Quality or Regulatory Affairs; 3+ years of leadership experience; 0-3 years of experience managing quality systems that require compliance with FDA Part 1271, FDA Part 820, ISO 13485 or AATB Standards. Additional experience may be considered in lieu of education requirement.

Certification: AATB Certified Tissue Bank Specialist (CTBS), preferred; Process Improvement Methodology certification, preferred

Skills: Excellent verbal and written communication; Quality Management System (QMS) software; Microsoft Office Suite, advanced Excel; Risk Management; Process Improvement Methodologies; Sampling Plans and Statistical techniques; Data Analysis

Travel: Minimal travel required, may occasionally travel for professional development or to support company initiatives, such as for audit support

Safety: Physical Requirement

• Move or lift objects up to 25 pounds
• Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
• Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)

Working Environment

Onsite: Office environment with assigned workstation. Remote positions only: Home office environment with minimum distractions.