Quality Engineering Manager
Lifecore Biomedical Inc
Summary
As a key technical leader, this position is responsible for developing, establishing and maintaining quality engineering and sterility assurance programs, policies, processes, procedures, and controls ensuring that the quality and sterility of components, raw materials and Lifecore manufactured clinical stage products conform to established requirements, standards, and regulatory requirements.
Job description
Technical and Team Leadership
- Lead Quality Engineering team supporting the quality system and clinical stage production processes
- Ensuring the design of production processes is sufficient to consistently attain a predefined quality at the end of the manufacturing process
- Ensuring that critical process parameters and adequate specifications are defined as appropriate for the product lifecycle phase
- Development and execution of process, equipment, sterilization and facility validation plans, protocols and reports
- Approval or rejection of raw materials, components, labeling, in-process and finished goods
- Review of production records and assurance of data integrity
- Ensuring that any errors that occur during production are fully investigated
- Approval or rejection of products manufactured, processed, packed, or held under contract at any other company
- Approval or rejection of procedures or specifications impacting the identity, strength, quality, and purity of product
- Risk management of production and quality system processes
- Approval or rejection of process and/or design changes
- Validation of equipment and/or processes as required
- Review and resource new business activities and improvement projects
- Support internal and external audit activities
- Oversee creation of validation master plans for product, facility and critical processes, as well as the associated validation activity
Required Education
- Bachelor's degree in Life Sciences or Engineering
- Certified Quality Engineer (CQE) or Professional Engineer (PE) certification preferred
Required Experience
- 8+ years of progressive experience in a medical device, biopharmaceutical, or other highly regulated manufacturing environment
- Experience in quality engineering, sterility assurance, and validation
- Experience leading technical teams
- Comprehensive understanding of GMP regulations for medical devices, pharmaceutical products and active pharmaceutical ingredients
Required Competencies
- Excellent organizational skills; capable of managing multiple dynamic, cross-functional projects simultaneously
- Ability to provide effective technical and personnel leadership to ensure team accountabilities are completed in a timely and satisfactory manner
- Proven ability to effectively define, organize, lead and prioritize workload
- Strong understanding of risk management and associated tools (FMEA, FTA, etc.)
- Experience in use of Quality Improvement tools (ex. flowcharts, DMAIC, process mapping, etc.)
- Demonstrated problem solving skills and the ability to train and develop others
- Established effective technical writing and oral communication skills
- Proven ability to envision and implement quality improvements
- Ability to effectively analyze and present data and concepts to a broad audience
Requirements
- 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 in quality engineering, sterility assurance, and validation
- Experience leading technical teams
- Comprehensive understanding of GMP regulations for medical devices, pharmaceutical products and active pharmaceutical ingredients
- Excellent organizational skills; capable of managing multiple dynamic, cross-functional projects simultaneously
- Ability to provide effective technical and personnel leadership to ensure team accountabilities are completed in a timely and satisfactory manner
- Proven ability to effectively define, organize, lead and prioritize workload
- Strong understanding of risk management and associated tools (FMEA, FTA, etc.)
- Experience in use of Quality Improvement tools (ex. flowcharts, DMAIC, process mapping, etc.)
- Demonstrated problem solving skills and the ability to train and develop others
- Established effective technical writing and oral communication skills
- Proven ability to envision and implement quality improvements
- Ability to effectively analyze and present data and concepts to a broad audience
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Short term disability
- Long term disability
- Life insurance
- Paid time off
- Paid holidays
- Paid family leave
- Tuition reimbursement
- 401k plan
- Company matching contribution
- Incentive bonus
Company overview
Lifecore Biomedical Inc is a leading U.S.-based contract development and manufacturing organization (CDMO) specializing in sterile injectable pharmaceuticals. Founded in 1965 and headquartered in Chaska, Minnesota, the company has established itself as a premier provider of end-to-end sterile injectable solutions for pharmaceutical and biotechnology companies. With over 40 years of expertise in pharmaceutical-grade sodium hyaluronate production, Lifecore offers comprehensive services spanning formulation development, process optimization, aseptic filling, and final packaging of complex injectable therapies. The company's capabilities include handling highly viscous solutions, sterile filtration, and manufacturing challenging drug products that require specialized expertise. Lifecore operates with a strong focus on quality and compliance, maintaining international certifications while supporting more than 25 commercial products globally. As a publicly traded company on Nasdaq under ticker LFCR, Lifecore continues to expand its role as a trusted partner in bringing innovative injectable treatments to patients worldwide.