Sr Quality Engineer (Medical Devices)

Location: Juncos, Puerto Rico, United States of America

Company

hirify.global develops healthcare technologies intended to alleviate pain, restore health, and extend life.

What you will do

• Provide quality leadership and oversight for daily manufacturing activities.
• Maintain quality standards and protocols for partially finished and finished products.
• Partner with engineering and manufacturing teams to establish and maintain quality standards.
• Design and implement inspection, testing, and evaluation methods for products and production equipment.
• Lead risk management, product disposition, problem solving, change control, and improvement initiatives.
• Support equipment and process validation activities and risk-burndown programs.

Requirements

• Bachelor’s degree in Engineering with at least 4 years of relevant experience, or a master’s degree with 2 years of relevant experience, or a PhD with no required experience.
• Advanced knowledge of GMP, FDA regulations, ISO 13485, and Quality System Regulations.
• Experience leading complex CAPA, NCMR, and root cause investigations.
• Expertise in Minitab, SPC, trend analysis, and other statistical analysis methods.
• Knowledge of manufacturing process controls, inspection optimization, process capability, digital quality systems, and data analytics.
• Unrestricted U.S. work authorization is required at hiring and throughout employment; sponsorship is not available for roles below Principal level.

Nice to have

• Lean Six Sigma Green Belt or Black Belt certification.
• Ability to coach and develop junior Quality Engineers.
• Experience leading site-wide quality culture initiatives.

Culture & Benefits

• Full-time employment with competitive compensation and flexible benefits.
• Eligibility for the hirify.global Incentive Plan short-term incentive.
• Reasonable accommodations are available for qualified individuals with disabilities.