Quality Engineer - Medical Devices | CAPA & Risk Mgmt

HR HealthCare; York (York County); Vor Ort; USD 80.000 - 110.000; Vollzeit

Zusammenfassung

HR HealthCare, a growing medical device company in York, PA, seeks a Quality Engineer who will ensure safety, effectiveness, and compliance across product lifecycles. You will work hands-on with contract manufacturers, suppliers, and cross-functional teams to solve quality issues and drive improvements.

Join a team where quality is central to product decisions. You’ll own risk management processes, support CAPAs/NCRs, and help maintain compliance with ISO 13485 and FDA QMSR requirements while

Qualifikationen

• Bachelor’s degree in engineering or related field.
• 3–5 years of product quality, development, and/or manufacturing experience in engineering/technical roles.

Aufgaben

• Maintain and improve assigned quality management system procedures, records, and controls.
• Coordinate maintenance of the risk management file and facilitate cross-functional ISO 14971 reviews.
• Draft, revise, and maintain Design History File for sourced finished goods.
• Review product verification and validation testing protocols and reports for acceptance criteria and data integrity.
• Develop product specifications, acceptance criteria, and sampling plans.
• Review testing per approved protocols or test plans.
• Perform first article inspections for sourced finished goods and components.
• Generate technical reports to summarize evaluation results.
• Develop and prepare specifications, work instructions, and inspection/testing documentation for sourced finished goods.
• Collaborate with contract manufacturers and suppliers to troubleshoot issues and implement corrective/preventive actions.
• Assist in CAPA and NCR resolution.
• Support post-market quality monitoring and feed findings into CAPA and risk management.
• Review engineering drawings for components and finished products.
• Use statistical tools to summarize product/process data.
• Promote compliance with internal policies; perform other duties as assigned.

Kenntnisse

Critical thinking

Problem-solving

Attention to detail

Teamwork

Communication

Ausbildung

Bachelor’s degree in engineering

Tools

MS Office

Minitab

Statistical analysis tools

Jobbeschreibung

HR HealthCare, a growing medical device company in York, PA, seeks a Quality Engineer who will ensure safety, effectiveness, and compliance across product lifecycles. You will work hands-on with contract manufacturers, suppliers, and cross-functional teams to solve quality issues and drive improvements.

Join a team where quality is central to product decisions. You’ll own risk management processes, support CAPAs/NCRs, and help maintain compliance with ISO 13485 and FDA QMSR requirements while