Quality Engineering Manager — Sterility & GMP Leader

Lifecore Biomedical, Inc.; Chaska (MN); On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

Learning & growth

Annual bonus

Health insurance

Dental & vision

Disability & life insurance

PTO 4 weeks

Holidays & personal days

Paid family leave

Tuition reimbursement

401k matching

Job summary

Lifecore Biomedical, Inc. in Chaska, MN, is seeking a Quality Engineering Manager to lead the quality engineering and sterility assurance programs for clinical stage products and manufacturing processes onsite.

You will establish and maintain quality systems, govern process validation, and manage materials approval, data integrity, and regulatory compliance while driving continuous improvement. The role requires a bachelor’s degree in life sciences or engineering and 8+ years in regulated

Qualifications

• Bachelor’s degree in Life Sciences or Engineering.
• 8+ years of progressive experience in a medical device, biopharmaceutical, or other highly regulated manufacturing environment.
• Experience leading technical teams and GMP regulations knowledge.
• Strong organizational skills and ability to manage multiple projects.

Responsibilities

• Lead Quality Engineering team supporting quality system and clinical stage production processes.
• Develop and execute process, equipment, sterilization and facility validation plans, protocols and reports.
• Approve or reject raw materials, components, labeling, in-process and finished goods.
• Oversee risk management and validation activities; support audits.

Skills

Quality engineering

Sterility assurance

Team leadership

GMP knowledge

Risk management

Data analysis

Education

Bachelor’s degree in Life Sciences or Engineering

Tools

FMEA

DMAIC

Process mapping

Validation protocols

Job description

Lifecore Biomedical, Inc. in Chaska, MN, is seeking a Quality Engineering Manager to lead the quality engineering and sterility assurance programs for clinical stage products and manufacturing processes onsite.

You will establish and maintain quality systems, govern process validation, and manage materials approval, data integrity, and regulatory compliance while driving continuous improvement. The role requires a bachelor’s degree in life sciences or engineering and 8+ years in regulated