Design Assurance Quality Engineer

United Pharma; Pennsylvania; On-site; USD 80,000 - 100,000; Full time

Job summary

United Pharma is seeking a Design Assurance Quality Engineer to ensure quality and regulatory compliance in product development. The role involves providing Design Assurance support, reviewing material specifications and inspections, and ensuring compliance with quality systems and standards. Candidates should have over 6 years of experience in medical device QA, a strong design assurance background, and familiarity with relevant regulatory standards. A Bachelor's degree in Engineering or a related field is required. Strong communication and stakeholder management skills are essential for success.

Qualifications

• 6+ years of experience in medical device quality assurance with a strong design assurance background.
• Solid knowledge of 21 CFR 820, ISO 13485, and related quality standards.
• Hands-on experience with FMEA, SPC, Minitab, and risk-based methodologies.

Responsibilities

• Provide Design Assurance and Quality Engineering support for product development activities.
• Review and support material specifications, drawings, inspections, and manufacturing SOPs.
• Ensure compliance with quality systems and regulatory standards.

Skills

Design Assurance

Quality Engineering

Regulatory compliance

Stakeholder management

Education

Bachelor’s degree in Engineering or related field

Tools

FMEA

SPC

Minitab

Job description

We are seeking a Design Assurance Quality Engineer to support product development initiatives for an innovative medical device organization. This role focuses on ensuring quality and regulatory compliance throughout the design and development lifecycle.

Key Responsibilities

• Provide Design Assurance and Quality Engineering support for product development activities
• Review and support material specifications, drawings, inspections, and manufacturing SOPs
• Ensure compliance with quality systems and regulatory standards
• Lead activities related to metrology, inspection systems, and non-conformance management
• Support risk management, CAPA, root cause analysis, and QA planning
• Review design transfer and tech transfer documentation for compliance
• Participate in cross-functional meetings and maintain accurate, compliant documentation

Required Qualifications

• 6+ years of experience in medical device quality assurance, with strong design assurance background
• Solid knowledge of 21 CFR 820, ISO 13485, and related quality standards
• Hands-on experience with FMEA, SPC, Minitab, and risk-based methodologies
• Bachelor’s degree in Engineering or related field
• Strong communication and stakeholder management skills