Sr Quality Engineer (Medical Devices)

TL;DR

Sr Quality Engineer (Medical Devices): Providing quality engineering leadership for machining and secondary operations to ensure product compliance with regulatory requirements with an accent on GMP, FDA, and ISO standards. Focus on driving compliance through disciplined documentation, analyzing quality risks, and supporting CAPA activities to ensure successful product launch.

Location: Humacao, Puerto Rico, United States. Must possess unrestricted U.S. work authorization.

Company

Global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life for millions of patients worldwide.

What you will do

• Lead quality engineering for machining and secondary manufacturing processes, including anodizing and final pack.
• Partner with Manufacturing and Engineering teams to define and sustain effective quality controls.
• Develop inspection, testing, and validation methods to ensure equipment and products meet established requirements.
• Apply statistical analysis and quality tools to evaluate process capability and investigate nonconformities.
• Manage product lifecycle quality activities, including change management and continuous improvement.
• Ensure all investigations, corrective actions, and validations are compliant and inspection-ready for audits.

Requirements

• Bachelor's degree in engineering.
• Minimum 4 years of relevant engineering, quality, or manufacturing experience (or Master's with 2 years).
• Experience working in a regulated manufacturing environment (medical devices, pharmaceutical, or similar).
• Working knowledge of quality systems, nonconformance handling, and CAPA.
• Ability to support manufacturing process quality activities and risk assessments.
• Unrestricted U.S. work authorization is required at the time of hire.

Nice to have

• Degree in Mechanical, Industrial, or Electrical engineering.
• Practical knowledge of ISO 13485 and FDA Quality System Regulations.
• Experience with validation concepts (URS, SRS, IQ, OQ, PQ).
• Proficiency with Minitab, JMP, Power BI, or SAP.
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience using AI tools (Python, Copilot, ChatGPT) to improve reporting and process analysis.

Culture & Benefits

• Competitive salary and flexible benefits package tailored to different life stages.
• Purpose-driven work environment focused on medical innovation and patient impact.
• Commitment to diversity, equity, and equal employment opportunity.
• Opportunities for professional growth within a global healthcare technology leader.