Senior Quality Engineer

United Pharma; Oregon (WI); On-site; USD 90,000 - 130,000; Full time

Job summary

United Pharma in Redmond, Oregon seeks an experienced Senior Quality Engineer to strengthen manufacturing quality, regulatory compliance, and quality systems. The role emphasizes validation, continuous improvement, and collaboration with cross-functional teams.

The ideal candidate will have strong experience in medical devices or other regulated manufacturing, with knowledge of ISO 13485, FDA/21 CFR 820, and QMS implementation. A proactive, communicative leader is essential for success.

Qualifications

• 5+ years of Quality Engineering experience in a manufacturing environment.
• Experience with ISO, FDA, and 21 CFR Part 820 requirements.
• ISO 13485 certification/experience.
• Industry experience in medical devices or other regulated manufacturing.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Develop and maintain quality procedures covering QMS, process control, validation, testing, inspection, and continuous improvement.
• Work with suppliers to investigate quality issues and ensure CAPA and SCAR actions are effectively implemented.
• Provide Quality support for Product Development, Design Control, Risk Management, Validation, and QMS activities.
• Create and maintain Device Master Records (DMRs) in accordance with regulatory requirements.
• Partner with Regulatory Affairs to support 510(k) submissions and related documentation.
• Monitor and maintain compliance with US and international regulatory standards.
• Review and approve design records, validation documentation, and quality-related records.
• Lead investigations into product nonconformances, process issues, and OOS results.
• Develop, implement, and monitor corrective and preventive actions.
• Train and mentor employees on quality systems and regulatory requirements.

Skills

Quality Engineering

Regulatory requirements

ISO 13485

Regulated industries

Communication

Tools

ETQ Reliance

Job description

We are seeking an experienced Senior Quality Engineer to support a medical supply manufacturing client in Redmond, Oregon. The ideal candidate will have a strong background in manufacturing quality, regulatory compliance, quality systems, validation, and continuous improvement.

Required Qualifications:

• 5+ years of Quality Engineering experience in a manufacturing environment
• Working knowledge of ISO, FDA, and 21 CFR Part 820 requirements
• ISO 13485
• Industry experience in medical devices, pharmaceuticals, aerospace, or other regulated manufacturing
• Strong communication, adaptability, cross-functional collaboration, and project management skills.

Preferred Experience:

• Experience with process, equipment, or software validation.
• Hands-on experience with Quality Management Systems (QMS), preferably ETQ Reliance.
• Experience managing or supporting employee training programs.

Key Responsibilities:

• Develop and maintain quality procedures covering QMS, process control, validation, testing, inspection, and continuous improvement.
• Work with suppliers to investigate quality issues and ensure CAPA and SCAR actions are effectively implemented.
• Provide Quality support for Product Development, Design Control, Risk Management, Validation, and QMS activities.
• Create and maintain Device Master Records (DMRs) in accordance with applicable regulatory requirements.
• Partner with Regulatory Affairs and internal teams to support 510(k) submissions and associated documentation.
• Monitor and maintain compliance with applicable U.S. and international regulatory standards.
• Review and approve design records, validation documentation, and quality-related records.
• Lead investigations involving product nonconformances, process issues, and out-of-specification (OOS) results.
• Develop, implement, and monitor effective corrective and preventive actions.
• Train and mentor employees on quality systems, procedures, regulatory requirements, and quality best practices.