Senior Product Quality Assurance Engineer

Lifecore Biomedical Inc • Chaska, MN

1d • $95,000 - $110,000 • Hybrid

About The Position

Lifecore is seeking a Senior Quality Engineer to provide quality oversight for a defined portfolio of product lines, lead complex investigations, CAPAs, cross‑functional projects, and QMS improvement initiatives. They will partner closely with manufacturing to ensure quality and compliance throughout the production of both clinical and commercial products. This is a hybrid position, with the option to work remotely up to two days per week.

Requirements

• BS in Engineering or Life Sciences.
• 5-8 years of Quality Assurance or Quality Engineering experience in an FDA regulated industry
• Technical writing and reviewing experience.
• Experience with statistics or statistical process control concepts.
• Experience supporting manufacturing operations.
• Excellent organizational and prioritization ability. Capability to manage multiple, dynamic projects simultaneously.
• Comprehensive understanding of GMP regulations for medical devices, pharmaceutical products and active pharmaceutical ingredients.

Nice To Haves

• Experience supporting audits and regulatory inspections (preferred).

Responsibilities

• Lead and coordinate quality support activities for a defined group of product lines or tasks.
• Support and/or define process improvement initiatives and process monitoring.
• Review process data trends to proactively identify potential quality problems, investigate root cause and implement effective corrective action.
• Perform batch record review and finished product disposition.
• Use quality engineering concepts to monitor, support and critically review additions, changes or issues to raw materials, product lines and/or critical processes.
• Define and review/approve appropriate controlled documentation.
• Provide clinical project support, including batch disposition and supplier quality activities including commercial readiness.
• Provide knowledge leadership and technical expertise for investigations, manufacturing processes, and inspection requirements.
• Lead investigations.

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: Senior