Quality Engineer I (Medical Devices)

Location: Humacao, Puerto Rico, United States of America; onsite role

Company

Global healthcare technology company developing medical technologies to alleviate pain, restore health, and extend life.

What you will do

• Develop, apply, and maintain quality standards and protocols for partially finished and finished products.
• Collaborate with engineering and manufacturing functions to establish and maintain quality standards.
• Design and implement inspection, testing, and evaluation methods for products and production equipment.
• Conduct quality assurance tests and statistical analyses to evaluate nonconforming products and materials.
• Ensure corrective measures meet reliability standards and maintain compliant documentation.
• Support quality activities across design, incoming materials, production control, product evaluation, inventory control, and research and development.

Requirements

• Baccalaureate degree in engineering; no relevant experience required.
• Engineering degree required.
• Unrestricted U.S. work authorization is required at the time of hire and throughout employment.
• For degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
• Ability to work independently, interact with computers, and communicate with peers and coworkers.

Nice to have

• Experience with Manufacturing Execution Systems, Quality Management Systems, document control, nonconformance management, CAPA, and change management.
• Knowledge of FDA QSR, ISO 13485, Six Sigma, Lean, DMAIC, FMEA, 5 Whys, or Fishbone analysis.
• Experience with statistical analysis tools such as Minitab and basic programming or scripting with VBA or Python.
• Industrial, Mechanical, or Electrical Engineering degree.
• Co-op or capstone experience in the medical devices industry.

Culture & Benefits

• Full-time employment with competitive compensation and a flexible benefits package.
• Eligibility for the hirify.global Incentive Plan short-term incentive.
• Equal employment opportunity and reasonable workplace accommodations.
• Work focused on healthcare technology, patient impact, and continuous improvement.