Quality Engineer I (Medical Devices)

Location: Juncos, Puerto Rico, United States of America; onsite role. Candidates must possess unrestricted U.S. work authorization at the time of hire and throughout employment.

Company

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

What you will do

• Develop, modify, apply, and maintain quality standards and protocols for materials and finished products.
• Support quality and supplier engineering activities involving product and process maintenance, equipment, materials, components, tooling, and manufacturing processes.
• Collaborate with quality, manufacturing, supply chain, regulatory, R&D, and laboratory partners to assess risk and implement controlled changes.
• Design or specify inspection and testing mechanisms and conduct quality assurance tests.
• Perform statistical analysis of products and materials that do not meet required standards.
• Ensure corrective actions meet reliability standards and documentation complies with applicable requirements.

Requirements

• Bachelor's degree in Engineering.
• Relevant experience: 0 years required.
• Unrestricted U.S. work authorization is required; sponsorship is not available for this role.
• For bachelor's degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• Problem-solving experience and knowledge of problem-solving techniques such as Kepner-Tregoe and DMAIC.
• Experience with regulatory agencies.
• Green Belt certification.
• Knowledge of statistical techniques and risk management standards.

Culture & Benefits

• Mission-driven work focused on healthcare technology and patient outcomes.
• Competitive compensation and a flexible benefits package.
• Eligibility for the hirify.global Incentive Plan short-term incentive.
• Reasonable accommodations are available for qualified individuals with disabilities.