Senior Quality & Sterility Engineering Lead

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

Benefits offered by this job

Medical insurance plans

HSA contributions

Dental insurance

Vision insurance

Disability insurance

PTO 4 weeks

Holidays

Family leave

Tuition reimbursement

401k matching

Job summary

Lifecore Biomedical, LLC in Chaska, MN is seeking a Quality Engineering Manager to lead the quality engineering and sterility assurance activities for clinical stage products. The role focuses on developing and maintaining programs, policies, and controls to ensure product quality and regulatory compliance.

The successful candidate will lead a technical team, drive process validation, risk management, and data-driven improvement initiatives, and partner with cross-functional teams to ensure

Qualifications

• Bachelor’s degree in Life Sciences or Engineering.
• 8+ years in a medical device or regulated manufacturing environment.
• Experience in quality engineering, sterility assurance, and validation.
• Experience leading technical teams.
• Comprehensive understanding of GMP regulations for medical devices and pharmaceutical products.
• Excellent organizational skills and ability to manage multiple projects.
• Strong technical leadership and data presentation abilities.
• Proven problem-solving and training capabilities.
• Effective technical writing and communication skills.
• Ability to implement quality improvements.

Responsibilities

• Lead Quality Engineering team supporting the quality system and clinical stage production processes.
• Develop and execute validation plans, protocols and reports for product, equipment, and facilities.
• Oversee risk management, design changes, and process improvements.
• Review production records and ensure data integrity.
• Support internal and external audits and Quality System initiatives.
• Oversee creation of validation master plans for product, facility and critical processes.

Skills

Quality engineering

Sterility assurance

Validation

Team leadership

GMP compliance

Risk management

Data analysis

Technical writing

Cross-functional leadership

Education

Bachelor’s degree in Life Sciences or Engineering

Tools

DMAIC

Job description

Lifecore Biomedical, LLC in Chaska, MN is seeking a Quality Engineering Manager to lead the quality engineering and sterility assurance activities for clinical stage products. The role focuses on developing and maintaining programs, policies, and controls to ensure product quality and regulatory compliance.

The successful candidate will lead a technical team, drive process validation, risk management, and data-driven improvement initiatives, and partner with cross-functional teams to ensure