Senior Quality Engineer - Medical Devices, Risk & Compliance

PRI-MiniMed Puerto Rico Operations Company; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

STI program

Flexible benefits package

Job summary

MiniMed is seeking a Sr Quality Engineer I to actively support compliant, efficient, patient-focused medical device manufacturing operations. You will lead investigations, handle nonconformances, and partner across functions in a regulated quality environment.

Responsibilities include developing quality standards, supporting document control, and implementing testing methods while ensuring proper documentation and reliability of processes and products.

Qualifications

• Engineering Bachelor Degree is required.
• Minimum 4 years of relevant experience, or 2 years with an advanced degree.

Responsibilities

• Develops, applies and maintains quality standards and protocol for processing materials into finished products.
• Collaborates with engineering and manufacturing to ensure quality standards are in place.
• Designs inspection/testing mechanisms; conducts quality assurance tests and statistical analyses.
• Ensures corrective actions meet reliability standards and documentation remains compliant.

Skills

Quality assurance

Root cause analysis

Process validation

Statistical analysis

Education

Engineering degree (Mechanical / Electrical / Chemical)

Tools

Minitab

pfMEA / risk management

URS / FAT / IQ / OQ / PQ

Job description

MiniMed is seeking a Sr Quality Engineer I to actively support compliant, efficient, patient-focused medical device manufacturing operations. You will lead investigations, handle nonconformances, and partner across functions in a regulated quality environment.

Responsibilities include developing quality standards, supporting document control, and implementing testing methods while ensuring proper documentation and reliability of processes and products.