Quality Assurance Engineer — Hybrid, Impactful GMP Role

Lifecore Biomedical Inc; Chaska (MN); Hybrid; USD 85,000 - 98,000; Full time

Benefits offered by this job

PTO 3 weeks

401k matching

Tuition reimbursement

Health insurance options

Job summary

Lifecore Biomedical, Inc. in Chaska, Minnesota, seeks a Quality Assurance Engineer to lead quality activities for commercial product lines and quality system processes. You will partner with Manufacturing to investigate issues, assess risk, drive CAPA, and ensure products meet regulatory and customer expectations.

The role is hybrid with the option to work remotely up to two days per week. A BS in Engineering or Life Sciences and 3–8 years in FDA-regulated QA/quality engineering are required.

Qualifications

• BS in Engineering or Life Sciences required.
• 3–8 years of Quality Assurance or Quality Engineering experience in an FDA regulated industry.
• Strong understanding of root cause analysis, CAPA, and quality systems.

Responsibilities

• Lead, support, and approve root cause investigations for nonconforming product, including corrective and preventive actions (CAPA).
• Provide quality engineering support for assigned product lines and/or critical processes.
• Establish, analyze and monitor quality trends and process capability data.
• Collaborate with cross-functional teams to participate in or facilitate risk analysis (e.g. FMEA) for product, process, or quality system changes.
• Review and approve quality records, procedures, and technical documentation; release product to customers.

Skills

Quality Assurance

Quality Engineering

Root cause analysis

CAPA

Manufacturing operations

Education

BS in Engineering or Life Sciences

Job description

Lifecore Biomedical, Inc. in Chaska, Minnesota, seeks a Quality Assurance Engineer to lead quality activities for commercial product lines and quality system processes. You will partner with Manufacturing to investigate issues, assess risk, drive CAPA, and ensure products meet regulatory and customer expectations.

The role is hybrid with the option to work remotely up to two days per week. A BS in Engineering or Life Sciences and 3–8 years in FDA-regulated QA/quality engineering are required.