Quality Engineer

About Avadim Holdings, Inc

Our Mission - To develop best-in-class accessible healthcare solutions that transform health and wellness. 

At Avadim Health, our mission is to help improve healthcare by creating breakthrough solutions that are accessible to everyone. We are dedicated to developing best-in-class healthcare innovations that not only enhance physical well-being but also empower individuals to take control of their health journey and live the life they want. Our commitment to excellence drives us to continually push the boundaries of what’s possible, fostering a healthier world for generations to come.

Our Vision - Empower people to enjoy healthier and happier lives. 

At Avadim Health, our vision drives us to continually innovate and evolve, always striving to exceed expectations and make a meaningful difference in the lives of those we serve. Through our innovative solutions, we strive to inspire positive change in the lives of people from every background. Together, our employees, our customers, and our partners embark on a journey towards a brighter, healthier future where everyone can thrive and enjoy life to the fullest. 

About the role

The Quality Engineer is responsible for determining production standards, establishing quality control systems, and setting product requirement rules.

What you'll do

Duties/Responsibilities:

• Implements audits throughout the supply chain, ensuring quality standards, safety and legal requirements, and company policies and specifications are met.
• Collaborates with clients, customers, and other stakeholders to identify and resolve problems with delivered products.
• Conducts or assists with performance and failure analysis of defective products or materials; identifies, recommends, or executes corrective actions.
• Provides quality engineering support for in-progress and final acceptance projects.
• Owner of process validations (IQ, OQ, PQ) and machine qualifications
• Develops and maintains a system to track and report projects and results of quality awareness programs and initiatives.
• Owner of DOE (Design of Experiments) and statistical analysis
• Drafts and recommends procedures to establish or improve quality standards, standard repairs, process controls, and inspection methods.
• Analyzes, reviews, and approves quality engineering policies, processes, documentation, and operations.
• Develops and implements strategies to increase quality and customization of products.
• Oversees data collection, analysis, validation and other research for quality projects.
• Interact with customers and suppliers on quality related issues.
• Facilitate problem solving and continuous improvement activities
• Develop and maintain process/product controls including process/equipment validations.
• Support supplier development for adequate controls and processes to assure product quality.
• Performs other duties as assigned.

Qualifications

Required Skills/Abilities:

• Excellent verbal and written communication skills.
• Excellent organizational skills and attention to detail.
• Strong analytical and problem-solving skills.
• Strong presentation, facilitation, and interpersonal skills.
• Preferred ASQ Six Sigma Green Belt and CQE certifications.
• Proficient with Microsoft Office Suite or related software.
• Minimum three years of related pharmaceutical manufacturing or other FDA regulated experience required.

Education and Experience:

Bachelor’s degree in Engineering; Quality, IE, or ME required