Technical certification in industrial mechanic or electronics
Knowledge of qsr and iso 13485 compliance
The role involves starting up equipment, monitoring product quality, and ensuring compliance with strict medical device regulations like QSR and ISO 13485
Job Summary
The role involves starting up equipment, monitoring product quality, and ensuring compliance with strict medical device regulations like QSR and ISO 13485.
Candidates must possess at least two years of experience in the medical device, pharmaceutical, or cosmetic industry along with relevant technical certifications.
The position requires performing routine preventive maintenance, utilizing Statistical Process Control, and maintaining a clean, safe work environment using 5S principles.
Matching Summary
The role involves starting up equipment, monitoring product quality, and ensuring compliance with strict medical device regulations like QSR and ISO 13485.
Skills & Requirements
Must-have
2 years experience in medical device industry
Technical certification in Industrial Mechanic or Electronics
Knowledge of QSR and ISO 13485 compliance
Ability to read drawings and schematics
Proficiency with SAP transactions for material use
Experience with Statistical Process Control (SPC)
Working knowledge of hydraulic, pneumatic, and mechanical systems
Nice-to-have
Bilingual Spanish and English proficiency
Strong initiative and team player attitude
Experience with MS Office and design programs
Commitment to cost reduction goals
Ability to differentiate electronic vs mechanical malfunctions
Key Requirements
Minimum 2 years experience in medical device or pharmaceutical industry
Technical Certification in Industrial Mechanic, Electronics, or related field
Minimum 6 months demonstrated proficiency on SM equipment
Compliance with GMP practices and safety laws
Ability to lift up to 25 pounds and stand most of the time