Quality Engineer

NML Medical; West Carrollton (OH); On-site; USD 70,000 - 80,000; Full time

Job summary

NML Medical is seeking a Quality Engineer in West Carrollton, Ohio. The successful candidate will design, implement, and maintain quality assurance protocols, ensuring compliance with internal and external standards for medical device manufacturing.

This role requires a bachelor’s degree and at least 2 years of relevant experience. Key responsibilities include conducting investigations, implementing quality systems, and supporting compliance with FDA regulations.

NML Medical values diversity and is committed to providing equal employment opportunities.

Qualifications

• Typically requires a bachelor’s degree and a minimum of 2 years of related experience.
• Proficient in computer technology including MS Office applications.
• Perform duties in compliance with applicable FDA and State regulations.

Responsibilities

• Design, implement, and maintain quality assurance protocols.
• Guide compliance of manufacturing processes with regulatory requirements.
• Conduct investigations on complaints or audit issues.

Skills

Computer technology proficiency

Analytical skills

Problem-solving skills

Teamwork

Attention to detail

Organizational skills

Education

Bachelor’s degree or equivalent experience

Job description

Position Summary

As a Quality Engineer, you will design, implement and maintain quality assurance protocols and methods for processing materials into finished products. Guide the compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standard requirements for worldwide distribution. Inspect, test and evaluate the precision and accuracy of production processes and equipment. Support the analysis of reports and production data to help identify trends and recommend updates or changes to quality standards and procedures. Uphold the company's quality standards and testing systems to reflect efficiency, reliability and performance. Assist in the creation of documentation to report issues and errors relating to the production process.

Essential Functions

• Reviews product and process changes for qualification and validation requirements, and assists in change implementations
• Implements systems to ensure timely quality inspections for incoming materials, components or finished goods products, and performs inspections as needed
• Conduct investigations on complaints or audit issues as quality system feedback is provided
• Supports the Non‑Conforming Material program and general Design Control activities such as risk assessment, design verification and validation, as well as sterilization and packaging validation
• Assists with new quality initiatives, participating in quality system development and procedure writing and review to improve the quality and reliability of products
• Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
• Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
• Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
• Performs other duties as assigned

Reasonable Accommodations

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

Qualifications

• Proficient in computer technology including MS Office applications, with good analytical and problem‑solving skills
• Able to work efficiently in a team environment
• Strong attention to detail and good organizational skills
• Perform duties in compliance with applicable FDA and State regulations as well as standards including, but not limited to, ISO 13485
• Typically requires a bachelor’s degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience

Physical Demands

• Required to sit; climb or balance; and stoop, kneel, crouch or crawl
• Required to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds
• Required to possess specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus

Equal Employment Opportunity

Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful.

Other Duties

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.