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

• This is a full-time, on-site position at our manufacturing facility in Swannanoa, NC. The Quality Engineer is responsible for providing leadership in all aspects of quality, validation and quality engineering throughout the organization, ensuring regulatory requirements, operational performance metrics and customer safety needs are met.
  
  

What The Quality Engineer Does

• Leads validation activities (IQ, OQ, PQ) and machine qualifications
• Supports Operations throughout the product life cycle
• 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
• Conducts risk assessments for products and processes
• Oversees and facilitates calibrations, preventative maintenance and environmental monitoring programs
• Provides quality engineering support for process and product improvements
• Leads DOE (Design of Experiments) and statistical analysis projects
• 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
• Oversees data collection, analysis, and other research for quality projects
• Interacts with customers and suppliers on quality related issues
• Facilitates problem solving and continuous improvement activities
• Develops and maintains process/product controls
• Supports supplier development for adequate controls and processes to assure product quality
• Performs other duties as assigned
  
  

Qualifications

• Excellent verbal and written communication skills
• Excellent organizational skills and attention to detail
• Able to work both independently and collaboratively with cross-functional team members
• 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
  
  

Education And Experience

• Bachelor's degree in science, engineering or related background
• Three to five years of relevant experience, preferably in pharmaceutical manufacturing
  
  

Physical Requirements

• Prolonged periods sitting at a desk and working on a computer
• Must be able to lift up to 15 pounds at times
• Must be able to travel to meet supply chain needs
• While performing the duties of this job, the employee is frequently exposed to fragrances or airborne particles and moving mechanical components.
  
  

[Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.]

Please Note

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Avadim Health Inc. is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

The Pay Range For This Role Is

65,000 - 84,000 USD per year(Swannanoa)

PI261777140