QA Technician — ISO/GMP Medical Devices

haemonetics; Pennsylvania; Sur place; USD 27 000 - 42 000; Plein temps

Avantages offerts par ce poste

401(k) match

Employee stock purchase plan

Flexible time off

Vacation time (hourly)

Paid sick time

Parental leave

Tuition reimbursement

Health and welfare benefits

Résumé du poste

Haemonetics is seeking a QA Technician to perform incoming and product inspections, maintain QC documentation, and ensure compliance with QSR/GMP, ISO 13485, MDD, and related regulations. The role emphasizes attention to detail and collaboration across teams.

The position involves various testing, record-keeping, and participation in calibration and environmental monitoring programs, with opportunities for growth in a regulated medical devices environment in Pennsylvania.

Qualifications

• High school diploma or GED required.
• Experience in a quality-related role preferred.
• Work experience in a highly detail-oriented environment.
• Computer proficiency required.
• Ability to communicate and collaborate on complex problem-solving

Responsabilités

• Accurately and promptly fill out required forms and paperwork documenting inspection and audit functions.
• Assist in the management of the calibration and environmental monitoring programs.
• Audit Product History Records, Sterilization Records, and other documentation as required, in order to prepare product for release.
• Carry out specialized testing and investigation as assigned to measure and quantify specific quality issues.
• May be required to perform other tasks as requested by group leader or supervisor. Perform inspection on incoming equipment/components per approved procedures.
• Assist in monitoring supplier quality trends and corrective action.
• Work with manufacturing to establish corrective action and assure effectiveness.
• Understand all quality requirements (ex. ISO, FDA regulation, etc.) with medical device manufacturing. Work with various chemicals such as alcohol in a safe manner.

Connaissances

Detail-oriented

Communication

Computer proficiency

Formation

High school diploma or GED

Description du poste

Haemonetics is seeking a QA Technician to perform incoming and product inspections, maintain QC documentation, and ensure compliance with QSR/GMP, ISO 13485, MDD, and related regulations. The role emphasizes attention to detail and collaboration across teams.

The position involves various testing, record-keeping, and participation in calibration and environmental monitoring programs, with opportunities for growth in a regulated medical devices environment in Pennsylvania.