Senior Quality Engineer – MedTech Process & CAPA Leader

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

Job summary

Medtronic is seeking a Senior Quality Engineer to lead quality activities for machining and secondary operations in a regulated environment in Puerto Rico. You will partner with Manufacturing, Engineering, and Quality teams to ensure GMP, FDA, and ISO compliance, and drive CAPA and continuous improvement efforts across the product lifecycle.

The role requires a Bachelor's degree in engineering with several years of experience in quality and manufacturing, plus strong data analysis,

Qualifications

• Requires a Bachelor's degree in engineering or higher.
• 4+ years of relevant engineering/quality experience in regulated manufacturing.
• Experience with GMP, FDA, and ISO regulatory expectations.
• Proficient in quality systems, documentation, CAPA, and change control.

Responsibilities

• Provide quality leadership for machining and secondary operations.
• Ensure compliance through disciplined documentation and audits.
• Lead investigations, CAPA, and corrective actions.
• Collaborate with Manufacturing, Engineering, Supply Chain, and Quality teams.
• Develop and implement quality controls for manufacturing processes.

Skills

Quality engineering

Regulatory knowledge

Data analysis

Root cause analysis

Cross-functional collaboration

Problem solving

Automation awareness

Education

Bachelor's degree in engineering

Master's degree in engineering

PhD (optional)

Tools

Minitab

JMP

Excel (advanced)

Power BI

SAP / ERP systems

Job description

Medtronic is seeking a Senior Quality Engineer to lead quality activities for machining and secondary operations in a regulated environment in Puerto Rico. You will partner with Manufacturing, Engineering, and Quality teams to ensure GMP, FDA, and ISO compliance, and drive CAPA and continuous improvement efforts across the product lifecycle.

The role requires a Bachelor's degree in engineering with several years of experience in quality and manufacturing, plus strong data analysis,