Quality Engineer, Medical Devices - Impact & Compliance

HR HealthCare; Springettsbury Township (York County); On-site; USD 75,000 - 120,000; Full time

Job summary

HR HealthCare is a fast-growing medical device company focused on development, manufacture, and supply of healthcare products. The Quality Engineer role entails acting as the technical voice to keep sourced finished goods safe, compliant, and reliable while collaborating with contract manufacturers and cross-functional teams.

You will maintain quality-system processes, review design and verification documentation, and support CAPA, NCRs, and supplier issues.

Qualifications

• Bachelor’s degree in engineering or related field.
• 3–5 years in product quality, development, or manufacturing in an engineering/technical role.
• Strong problem solving and root cause analysis skills.

Responsibilities

• Maintain and improve quality-management system procedures and controls.
• Coordinate risk management file using ISO 14971 framework.
• Review DHF, V&V, specifications and sampling plans.
• Lead first article inspections for sourced finished goods and components.
• Assist CAPA, NCRs, and change controls; support post-market surveillance.
• Analyze product/process data with statistical tools and communicate findings.

Skills

Quality engineering

Root cause analysis

Statistical analysis

Reading drawings

Education

Bachelor’s degree in engineering

Tools

Minitab

MS Office

Job description

HR HealthCare is a fast-growing medical device company focused on development, manufacture, and supply of healthcare products. The Quality Engineer role entails acting as the technical voice to keep sourced finished goods safe, compliant, and reliable while collaborating with contract manufacturers and cross-functional teams.

You will maintain quality-system processes, review design and verification documentation, and support CAPA, NCRs, and supplier issues.