Design Quality Engineer: Lead Validation & Quality Systems

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

Benefits offered by this job

Medical insurance plans

HSA plan with company contributions

Dental and vision insurance

Short term disability

Long term disability

Life insurance

PTO 3 weeks

Holidays 9 + 2 personal

Paid family leave

Tuition reimbursement

401k with company match

Incentive bonus

Job summary

Lifecore Biomedical, Inc. in Chaska, MN is seeking a Design Quality Engineer to join the MS&T team. This full-time role provides quality engineering support for process and equipment validation, new product development, and customer interactions during development activities.

You will apply QbD principles to ensure products meet quality and regulatory requirements. The position offers a 4- or 5-day work week option and a comprehensive benefits package.

Qualifications

• BS in Engineering or Life Sciences required.
• 2-5 years’ experience in QA or QE 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 and equipment or facility qualification projects.
• Develop validation strategies based on product risk and regulatory requirements.
• Review and approve protocols, reports, and other quality records.
• Qualify new equipment, facility changes, utilities, and manufacturing processes via IQ/OQ/PQ/PPQ.
• Establish and monitor process trends, metrics, and process capability data.
• Facilitate risk assessments related to quality systems and product changes.
• Review Change Orders for quality and regulatory impact.
• Collaborate with cross-functional teams and customers on product development and continuous improvement.

Skills

Quality Assurance

Quality Engineering

Process validation

Risk management

Education

BS in Engineering or Life Sciences

Job description

Lifecore Biomedical, Inc. in Chaska, MN is seeking a Design Quality Engineer to join the MS&T team. This full-time role provides quality engineering support for process and equipment validation, new product development, and customer interactions during development activities.

You will apply QbD principles to ensure products meet quality and regulatory requirements. The position offers a 4- or 5-day work week option and a comprehensive benefits package.