Manufacturing Engineer II - Packaging & Process Validation

Quality Consulting Group, LLC; Villalba (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

QUALITY CONSULTING GROUP is seeking a qualified professional to join a world-class team in Puerto Rico & USA. You will lead in change control, device qualification, and validation activities across manufacturing, packaging and laboratory equipment, ensuring compliance with FDA Part 820 and GMP standards.

Responsibilities include designing packaging for terminally sterilized devices per ISO 11607-1, validating forming/sealing/assembly per ISO 11607-2, and performing root-cause investigations with

Qualifications

• Bachelor’s degree in Engineering is required.
• 3+ years of relevant experience.
• Strong knowledge of FDA Medical Devices Part 820 Quality System Regulation & GMP.
• Process Validation, Equipment IQ and Computer Software validation knowledge.
• Technical writing and communication skills.
• Investigation and root cause analysis skills.
• Experience with packaging processes for terminally sterilized medical devices per ISO 11607.
• Shift: 1st shift and 2nd shift.

Responsibilities

• Change control of Medical Devices
• Equipment Commissioning / Qualification
• Process Validation
• Computer System Validation (CSV)
• Manufacturing, Packaging and Laboratory Equipment
• Quality / Process Control / Assurance of Medical Devices
• Design and development of a packaging system for terminally sterilized medical devices as per ISO 11607-1 requirements
• Validation of processes for packaging medical devices per ISO 11607-2 requirements
• These processes include forming, sealing and assembly of barrier systems
• Investigations and corrective actions to ensure product quality
• Collaborate with cross-functional teams to address quality issues and improvements

Skills

Change control

Equipment commissioning

Process validation

CSV (Computer System Validation)

Quality assurance

Packaging system design

Root cause analysis

Technical writing

Bilingual English/Spanish

Manufacturing process improvement

Education

Bachelor’s degree in Engineering

Job description

QUALITY CONSULTING GROUP is seeking a qualified professional to join a world-class team in Puerto Rico & USA. You will lead in change control, device qualification, and validation activities across manufacturing, packaging and laboratory equipment, ensuring compliance with FDA Part 820 and GMP standards.

Responsibilities include designing packaging for terminally sterilized devices per ISO 11607-1, validating forming/sealing/assembly per ISO 11607-2, and performing root-cause investigations with