Senior Quality Engineer — CAPA & GMP Leader

Medtronic; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Medtronic in Juncos, Puerto Rico, is seeking a Senior Quality Engineer to lead quality initiatives within a regulated manufacturing environment. You will partner with engineering and manufacturing to implement quality standards, drive investigations, and support continuous improvement to enhance compliance and reliability.

Key responsibilities include leading CAPA/NCMR/root-cause efforts, applying SPC and data analysis, and ensuring GMP/FDA/ISO13485 compliance.

Qualifications

• Bachelor's in Engineering with 4+ years quality experience in regulated manufacturing.
• Experience investigations, nonconformances, and corrective actions.
• Experience using statistics to evaluate process performance.
• Ability to collaborate with engineering, manufacturing, and QA teams.
• Knowledge of GMP, FDA, ISO 13485, and internal procedures.

Responsibilities

• Lead CAPA, NCMR, and root-cause investigations.
• Collaborate with engineering and manufacturing to improve quality standards.
• Develop and maintain quality protocols and inspection strategies.
• Design and execute inspection, testing, and evaluation methods.
• Apply SPC and trend analysis to monitor performance.
• Assess nonconformances and ensure corrective actions meet reliability.
• Support GMP, FDA, ISO13485 compliance and internal procedures.
• Mentor junior quality engineers.

Skills

Capable with quality engineering

Statistical analysis

Cross-functional collaboration

Root cause analysis

GMP/FDA/ISO13485 knowledge

Education

Bachelor's Degree in Engineering

Master's Degree or PhD

Tools

Minitab

SPC

Lean Six Sigma (Green/Black Belt)

Job description

Medtronic in Juncos, Puerto Rico, is seeking a Senior Quality Engineer to lead quality initiatives within a regulated manufacturing environment. You will partner with engineering and manufacturing to implement quality standards, drive investigations, and support continuous improvement to enhance compliance and reliability.

Key responsibilities include leading CAPA/NCMR/root-cause efforts, applying SPC and data analysis, and ensuring GMP/FDA/ISO13485 compliance.