Quality Engineering Technician — Drive Quality & Compliance

Praxis Technology; Town of Queensbury (NY); Sur place; USD 60 000 - 85 000; Plein temps

Avantages offerts par ce poste

Health insurance $1/month

401k with company match

Life AD&D Insurance

Employee Assistance Program

Paid time off - 18 days

Paid holidays - 9 days

Annual performance bonus potential

Profit sharing

Tuition assistance

Shift differential: 2nd +1/hr, 3rd +3/

Résumé du poste

Praxis Technology is seeking a Quality Engineering Technician to help ensure the production of high-quality medical device products. You will uphold our QMS, perform root cause analysis, and drive CAPA activities to prevent recurrence while collaborating with cross-functional teams.

The role emphasizes auditing, inspections, and continuous improvement initiatives, with a strong emphasis on ISO 13485 and regulatory compliance.

Qualifications

• Strong analytical and problem-solving abilities required.
• Familiarity with quality management systems and tools.
• Detail-oriented with a focus on root cause analysis.
• Excellent interpersonal and collaboration skills across levels.
• Demonstrated verbal and written communication and technical writing.
• Working knowledge of ISO 13485.

Responsabilités

• Perform root cause investigations of non-conformities and implement corrective actions.
• Support CAPA to improve the quality management system.
• Maintain computerized maintenance management system; enter equipment changes.
• Support calibration program; ensure timely calibrations.
• Create and implement quality controls with monitoring, sampling, and inspection methods.
• Develop and implement quality systems, records, and procedures for regulatory compliance.
• Assist internal audits to assess QMS effectiveness.
• Conduct regular inspections and audits to identify defects or non-compliance.
• Provide training to employees on quality standards.
• Support external audits by regulators and customers.
• Lead continuous improvement projects in quality, productivity, and safety.
• Monitor quality metrics and trend analysis.
• Review lot history records and issue certificates of conformance.

Connaissances

Strong analytical and problem-solving

Quality management systems

Root cause analysis

Interpersonal skills

Verbal and written communication

Technical writing

ISO 13485 knowledge

Outils

Quality management tools

Description du poste

Praxis Technology is seeking a Quality Engineering Technician to help ensure the production of high-quality medical device products. You will uphold our QMS, perform root cause analysis, and drive CAPA activities to prevent recurrence while collaborating with cross-functional teams.

The role emphasizes auditing, inspections, and continuous improvement initiatives, with a strong emphasis on ISO 13485 and regulatory compliance.