Hybrid QA Engineer: Lead Quality for Medical Devices

Lifecore Biomedical; Chaska (MN); Híbrido; USD 85 000 - 98 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical insurance plans (HSA)

Dental insurance

Vision insurance

Disability insurance

Life insurance

PTO 3 weeks

Company holidays

Personal holidays

Family leave

Tuition reimbursement

401k with company match

Resumo da oferta

Lifecore Biomedical in Chaska, MN is seeking a Quality Assurance Engineer to lead quality engineering for medical device/pharma product lines and quality system processes. You will partner with Manufacturing to investigate issues, assess risk, and drive improvements.

The role supports a hybrid work model with remote options up to two days per week. Candidates should have a strong QA background in FDA-regulated environments and a BS in Engineering or Life Sciences.

Qualificações

• Experience leading quality engineering activities in medical device/pharma settings.
• Strong background in CAPA, RCA, and quality systems.
• Experience supporting manufacturing operations in FDA-regulated environments.

Responsabilidades

• Lead root cause investigations for nonconforming product and CAPA.
• Provide quality engineering support for assigned product lines and processes.
• Establish and monitor quality trends and process capability data.
• Collaborate in risk analysis (FMEA) for product/process/quality system changes.
• Review and approve quality records, procedures, and release products.

Conhecimentos

Quality engineering

CAPA

Root cause analysis

Manufacturing support

FDA regulated environment

Formação académica

BS in Engineering or Life Sciences

Descrição da oferta de emprego

Lifecore Biomedical in Chaska, MN is seeking a Quality Assurance Engineer to lead quality engineering for medical device/pharma product lines and quality system processes. You will partner with Manufacturing to investigate issues, assess risk, and drive improvements.

The role supports a hybrid work model with remote options up to two days per week. Candidates should have a strong QA background in FDA-regulated environments and a BS in Engineering or Life Sciences.