Design Quality Engineer: QbD & Validation Leader

Lifecore Biomedical Inc; Chaska (MN); On-site; USD 80,000 - 92,000; Full time

Benefits offered by this job

4.5 or 5 day work week

Competitive salary and benefits

Company-provided benefits starting at

Job summary

Lifecore Biomedical, Inc. in Chaska, MN, is seeking a Design Quality Engineer to join our MS&T team.

In this role you will apply QbD principles to ensure products, processes, and systems meet quality and regulatory requirements during new product development. You will lead quality activities for equipment, systems, and manufacturing processes, support new process development and technology transfer, and develop validation strategies based on risk and regulatory needs.

Qualifications

• BS in Engineering or Life Sciences.
• 2-5 years’ experience in Quality Assurance or Quality Engineering in an FDA regulated industry.
• Experience in process/equipment validation (Preferred).
• Background in biology and/or chemistry production processes is a strong plus.

Responsibilities

• Lead quality system activities related to equipment, systems, and manufacturing processes, including validation, report generation, investigations, and process trending.
• Provide quality engineering support for new process development, technology transfer activities, and equipment or facility qualification projects.
• Develop validation strategies based on product risk, process understanding, and applicable regulatory requirements.
• Review and approve controlled documentation, including validation protocols and reports, production-related documents, nonconformities, validation deviations, and other quality records.
• Qualify new equipment, facility changes, utilities, and manufacturing processes through IQ/OQ/PQ/PPQ activities.
• Establish, analyze, and monitor process trends, performance metrics, and process capability data for systems, processes, and products.
• Facilitate and document risk assessments related to quality systems, new process development, process improvements, and product changes.
• Review and approve Change Orders to ensure appropriate assessment of quality and regulatory impact.
• Partner with cross-functional teams and customers to support successful product development, commercialization, and continuous improvement initiatives.

Skills

Quality Assurance

Quality Engineering

Regulatory compliance

Process validation

Risk management

Education

BS in Engineering

Job description

Lifecore Biomedical, Inc. in Chaska, MN, is seeking a Design Quality Engineer to join our MS&T team.

In this role you will apply QbD principles to ensure products, processes, and systems meet quality and regulatory requirements during new product development. You will lead quality activities for equipment, systems, and manufacturing processes, support new process development and technology transfer, and develop validation strategies based on risk and regulatory needs.