Senior Product Quality Assurance Engineer

It's not what we make, it's what we make possible. And the possibilities at Lifecore are endless!

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 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.

In this critical role, you will:

• 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.

This position could be a great fit for you if you have a passion for quality along with the following:

• 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 audits and regulatory inspections (preferred).
• 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.

Starting Salary: $95,000 - $110,000 annually with consideration for relevant experience

Lifecore offers a highly competitive total rewards package, including:

• Opportunities to learn and grow with a well-respected company
• Competitive compensation with annual reviews and a company-wide incentive bonus
• Benefits that start the first of the month after you join Lifecore as a full-time employee:
• 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

Meet Lifecore Biomedical, LLC:

Lifecore Biomedical, Inc. (Nasdaq: LFCR) 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.