Associate Quality Engineer (Medical Devices)

Location: Methuen, MA, 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

• Provide real-time quality support to manufacturing operations, identify defects, perform root-cause analysis, and implement corrective actions.
• Lead containment, risk-based evaluation, disposition, and closure of nonconforming material records; facilitate Material Review Board activities.
• Support CAPA execution, production monitoring, inspection and testing methods, measurement systems analysis, and process capability improvements.
• Review document change orders, engineering drawings, specifications, risk management files, and verification and validation documentation for compliance, risk controls, and traceability.
• Support manufacturing process validation, including equipment installation, operational, and performance qualification activities.
• Assess supplier quality documentation, collaborate with cross-functional teams, and support internal and external audit preparation and observation closure.

Requirements

• Bachelor’s degree required; a science or engineering degree is preferred.
• 0–2 years of quality assurance experience; medical device industry experience is preferred.
• Experience with GMP and ISO requirements, including ISO 13485 quality systems.
• Strong proficiency in Microsoft Office and knowledge of statistical analysis tools.
• Strong critical-thinking, problem-solving, written communication, and verbal communication skills.
• Ability to work collaboratively in a deadline-driven environment and perform the stated physical functions, including lifting up to 25 pounds occasionally.

Nice to have

• Knowledge of Lean Manufacturing, Six Sigma, and reliability engineering.
• Experience in the medical device industry.

Culture & Benefits

• Work is guided by innovation, customer focus, teamwork, and a results-driven approach.
• Maintain compliance with United States and international medical device regulations and applicable company codes.
• Participate in introductory and annual compliance training.
• Inclusive equal opportunity workplace committed to a diverse and respectful workforce.