Senior Quality Engineer (Medtech)

TL;DR

Senior Quality Engineer (Medtech): Developing and maintaining quality standards and protocols for medical device manufacturing with an accent on regulatory compliance, risk management, and process validation. Focus on ensuring product reliability, conducting investigations, and driving continuous improvement initiatives within a highly regulated environment.

Location: Must be based in Humacao, Puerto Rico, United States

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through innovative medical solutions.

What you will do

• Develop and maintain quality standards and protocols for material processing and finished products.
• Collaborate with engineering and manufacturing teams to ensure adherence to quality standards.
• Design and implement inspection and testing mechanisms to evaluate product precision and accuracy.
• Perform statistical analysis to assess product performance and determine root causes for non-conformances.
• Ensure corrective measures meet reliability standards and maintain audit-ready documentation.
• Provide guidance and coaching to lower-level specialists and manage quality-related projects.

Requirements

• Bachelor’s degree in engineering required (Mechanical, Industrial, or Electrical preferred).
• Minimum of 4 years of relevant engineering, quality, or manufacturing experience (or 2 years with a Master’s degree).
• Must possess unrestricted U.S. work authorization at the time of hire.
• Experience working in a regulated manufacturing environment (medical devices, pharmaceutical, or similar).
• Working knowledge of quality systems including nonconformance handling, CAPA, and change control.
• Strong technical writing skills for protocols, reports, and quality documentation.

Nice to have

• Practical knowledge of ISO 13485 and FDA Quality System Regulations.
• Experience with validation concepts (IQ, OQ, PQ) and risk management tools (FMEA).
• Lean Six Sigma Green or Black Belt certification.
• Experience with data analysis tools such as Minitab, JMP, or Power BI.
• Familiarity with automation and AI tools (Python, VBA, Copilot) for process improvement.

Culture & Benefits

• Competitive salary and comprehensive benefits package.
• Participation in the hirify.global Incentive Plan (MIP).
• Commitment to equal employment opportunity and inclusive work environment.
• Opportunities for professional growth and impact in a global healthcare leader.