Quality Engineer (MedTech)

Location: West Carrollton, OH, United States

Company

hirify.global develops medical technologies and solutions that improve surgical techniques and outcomes for patients with musculoskeletal disorders.

What you will do

• Design, implement, and maintain quality assurance protocols for manufacturing processes and finished products.
• Review product and process changes for qualification and validation requirements and support change implementation.
• Establish timely quality inspections for incoming materials, components, and finished goods.
• Investigate customer complaints and audit issues and support the non-conforming material program.
• Support design control activities, including risk assessment, design verification and validation, and sterilization and packaging validation.
• Contribute to quality-system development, procedure writing, data analysis, and continuous improvement initiatives.

Requirements

• Bachelor’s degree and at least 2 years of related experience, or an advanced degree without experience, or equivalent work experience.
• Knowledge of FDA and state regulations and standards including ISO 13485.
• Proficiency with computer technology and MS Office applications.
• Strong analytical, problem-solving, organizational, and attention-to-detail skills.
• Ability to work efficiently in a team environment.
• Ability to meet the stated physical and vision requirements, including lifting up to 25 pounds occasionally.

Culture & Benefits

• Work focused on improving patient care through medical technology innovation.
• Values include innovation, customer focus, teamwork, and driven execution.
• Commitment to an inclusive and respectful workplace.
• Employment is full time.