Associate Director Quality Assurance

Associate Director Quality Assurance

Location: Raleigh, NC

Pay Rate: $45-50/HR Monday to Friday, from 8:00 to 5:00, 3 days a week in the Raleigh office

The Associate Director, Quality Assurance, is responsible for the global strategic management and oversight of R&D Quality activities and associated staff related to Good Manufacturing Practices (GMP) for non-Energy Based Devices (EBD) and EBD Medical Devices. Activities include, but not limited to general Product Development / Design Control customer input, specification development, verification and validation testing, manufacturing transfer, risk assessment, usability, design change control, etc. This role will operate as a liaison among the various R&D functions and the Quality Operations department to assure global strategic alignment and compliance.

Major Duties

• Staff Management
• R&D Quality Management and Oversight
• Quality Activities for Medical Device Manufacturing and Design & Risk Management
• Human Factors Engineering
• Audits
• General R&D Support
• R&D Quality Improvements
• Quality Intelligence
• Further Tasks
• Other Duties Assigned

Leadership Responsibilities

Articulate a clear and compelling vision aligned with the global cultural tenets and strategic objectives of the company. Clearly define roles and responsibilities while holding members accountable for their performance. Develop talent and skills of individual team members Empower leaders and employees to make informed decisions, enabling autonomy while providing guidance and support.

Education

Bachelor's Degree in Engineering or Life/Health Sciences Preferred: Master's Degree

Additional Licenses and Certifications

Certification(s) – ASQ Certified Quality Engineer or equivalent - preferred

Technical & Functional Skills

Proficient in all MS Office applications Demonstrated organizational skills, ability to independently prioritize work and detail oriented Strong verbal, written communication, and emotional intelligence skills Ability to effectively multitask and manage multiple projects Experience with FDA, European agency regulations, cGMP regulations, and Quality Management software is highly preferred. Knowledge of regulatory requirements and standards for a medical device organization (i.e., 21CFR820, ISO 13485, ISO 14971, IEC 62304) Ability to work effectively in a global, matrix environment Ability to travel up to 15%

Physical Requirements

This job requires various physical activities and environmental conditions that employees must be prepared to handle. Key physical requirements include standing, sitting, walking, and bending, with tasks involving repetitive movements and handling objects of different weights, ranging from light (under 5 lbs) to heavy (over 20 lbs). Employees will also need to operate machinery such as computers, copiers, and telephones, and perform tasks requiring manual dexterity and visual acuity. The working environment may expose employees to different temperatures, noise levels, and other conditions like humidity and heights. Sensory requirements include near and far visual acuity, color discrimination, hearing, and speech. Additionally, some roles may involve local, national, or international travel (up to 20%). These requirements ensure that the job is performed effectively while accommodating employees' needs in compliance with the Americans with Disabilities Act (ADA).

Work Experience

7 - 8 years of relevant Quality medical device development experience Energy-Based Device Experience Knowledge of Class II, 510K, 21CFR 820, ISO 13485, IEC 606011, ISO 14971