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 is a hybrid position, with the option to work remotely up to two days per week.
In this critical role, you will:
- 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
This position could be a great fit for you if you have a passion for problem solving, and the following:
- BS in Engineering or Life Sciences
- 3 - 8 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
- Background in biology and/or chemistry production processes a strong plus!
Starting Salary: $85,000 - $98,000 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
- Family leave
- Tuition reimbursement
- 401k plan with company matching contribution
