Quality Assurance Engineer

Lifecore Biomedical Inc • Chaska, MN

6h • Hybrid

About The Position

Lifecore is seeking a Quality Assurance Engineer to lead quality engineering activities for assigned commercial medical device or pharmaceutical product lines and/or quality system processes. This role ensures finished products consistently meet quality standards, regulatory requirements, and customer expectations. You will serve as a key quality partner to Manufacturing, using quality engineering tools to investigate issues, assess risk, and drive continuous improvement across processes, equipment, and quality systems. This full-time position offers incredible benefits, your choice of a 4 ½ or 5 day work week, and a company culture focused on development and growth which include promotion opportunities. Lifecore Biomedical, Inc. is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials, and cartridges, including complex formulations. As a leading manufacturer of premium, injectable-grade hyaluronic acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories. This is a hybrid position, with the option to work remotely up to two days per week.

Requirements

• BS in Engineering or Life Sciences
• 2-5 years of Quality Assurance or Quality Engineering experience in an FDA regulated industry
• Strong understanding of root cause analysis, CAPA, and quality systems
• Experience supporting manufacturing operations

Nice To Haves

• Background in biology and/or chemistry production processes a strong plus!

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

Benefits

• Opportunities to learn and grow with a well-respected company
• Competitive compensation with annual reviews and a company-wide incentive bonus
• 3 medical insurance plans to fit your needs and budget including an HSA Plan with a generous company contribution
• Low cost dental and vision insurance
• Short term disability, long term disability and life insurance all 100% company paid
• 3 weeks PTO in the first year (increases to 4 weeks after just 2 years!)
• 9 paid company holidays plus 2 personal holidays
• Paid family leave
• Tuition reimbursement
• 401k plan with company matching contribution

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees