QA Technician — Medical Devices & Compliance

Haemonetics Interventional Technologies; Pennsylvania; On-site; USD 28,000 - 43,000; Full time

Benefits offered by this job

401(k) with up to 6% match

Employee stock purchase plan

Flexible time off

Vacation days for hourly employees

Paid sick time

paid holidays

Parental leave

Disability insurance

Tuition reimbursement

Health and welfare benefits

Job summary

Haemonetics Interventional Technologies is seeking a QA Technician to perform incoming inspections, product inspections, and related testing, while maintaining QC documentation and ensuring compliance with QSR/GMP, ISO 13485, and other applicable regulations.

The role requires attention to detail, collaboration with manufacturing, and support for calibration and environmental monitoring programs, with strong computer skills and team-oriented problem solving.

Qualifications

• High school diploma or GED equivalent, 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 #LI-AR1

Responsibilities

• 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.

Skills

Detail-oriented

Computer skills

Communication

Quality experience

Education

High school diploma or GED

Job description

Haemonetics Interventional Technologies is seeking a QA Technician to perform incoming inspections, product inspections, and related testing, while maintaining QC documentation and ensuring compliance with QSR/GMP, ISO 13485, and other applicable regulations.

The role requires attention to detail, collaboration with manufacturing, and support for calibration and environmental monitoring programs, with strong computer skills and team-oriented problem solving.