Quality Assurance Technician — Medical Devices & Compliance

Haemonetics; Pennsylvania; Sur place; USD 28 000 - 43 000; Plein temps

Avantages offerts par ce poste

401(k) with up to 6% employer match

Employee stock purchase plan

Flexible time off for salaried staff

Vacation (three to five weeks annually

Paid sick time (64 hours annually)

Paid holidays

Parental leave

Disability insurance

Tuition reimbursement

Health and welfare benefits

Résumé du poste

Haemonetics is seeking a QA Technician in the United States (PA) to perform incoming and product inspections and related testing, while maintaining QC documentation and adhering to QSR/GMP, ISO 13485, and other regulations. You will audit records and assist in calibration, environmental monitoring, and supplier quality trends.

The role requires attention to detail, strong communication, and the ability to work with manufacturing to implement corrective actions and ensure regulatory compliance.

Qualifications

• High school diploma or GED equivalent.
• Experience in a Quality related role preferred.
• Detail-oriented environment experience.
• Computer proficiency required.
• Ability to communicate and collaborate on complex problems.

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 & collaboration

Computer proficiency

Formation

High school diploma or GED

Description du poste

Haemonetics is seeking a QA Technician in the United States (PA) to perform incoming and product inspections and related testing, while maintaining QC documentation and adhering to QSR/GMP, ISO 13485, and other regulations. You will audit records and assist in calibration, environmental monitoring, and supplier quality trends.

The role requires attention to detail, strong communication, and the ability to work with manufacturing to implement corrective actions and ensure regulatory compliance.