Quality Engineer II - Validation & CSV Specialist

Medial Group; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Medial Group seeks a Quality Engineer II to support manufacturing validation and regulatory-compliant quality activities in a regulated medical device environment. You will execute PV and equipment qualification, assist CSV efforts, and help ensure product quality and process control throughout the design-to-production transfer.

The role collaborates with Engineering, Manufacturing and Quality teams to implement validation strategies, assess risk, and drive continuous compliance with regulatory

Qualifications

• 2+ years of experience in validation processes.
• Hands-on experience with PV and Equipment Qualification / CSV.
• Experience with risk management documentation (pFMEA).
• Basic knowledge of validation strategy development.
• Basic statistical knowledge; Minitab preferred.

Responsibilities

• Perform and/or review PV activities incl. OQ/PQ; exclude cleaning validations.
• Execute Equipment Qualification and CSV activities (URS, FAT, IQ, OQ, PQ, TMV).
• Support definition and execution of validation strategies from design to manufacturing.
• Develop and maintain risk documentation including pFMEA.
• Assist design transfer and manufacturing controls validation.

Skills

Process Validation

Equipment Qualification

CSV

Risk management

Minitab

Statistical analysis

Education

Engineering degree (Mechanical/Electrical/Chemical)

Tools

Minitab

Job description

Medial Group seeks a Quality Engineer II to support manufacturing validation and regulatory-compliant quality activities in a regulated medical device environment. You will execute PV and equipment qualification, assist CSV efforts, and help ensure product quality and process control throughout the design-to-production transfer.

The role collaborates with Engineering, Manufacturing and Quality teams to implement validation strategies, assess risk, and drive continuous compliance with regulatory