We are seeking a
DesignQuality Engineer to join our MS&T team. In this role, you will provide quality engineering expertise in support of process and equipment validation, new business development, and customer interactions during new product development activities. This role applies Quality by Design (QbD) principles and effective risk management practices to ensure products, processes, equipment, and systems meet quality and regulatory requirements.
In this critical engineering role, you will:
- Lead quality system activities related to equipment, systems, and manufacturing processes, including validation, report generation, investigations, and process trending.
- Provide quality engineering support for new process development, technology transfer activities, and equipment or facility qualification projects.
- Develop validation strategies based on product risk, process understanding, and applicable regulatory requirements.
- Review and approve controlled documentation, including validation protocols and reports, production-related documents, nonconformities, validation deviations, and other quality records.
- Qualify new equipment, facility changes, utilities, and manufacturing processes through IQ/OQ/PQ/PPQ activities.
- Establish, analyze, and monitor process trends, performance metrics, and process capability data for systems, processes, and products.
- Facilitate and document risk assessments related to quality systems, new process development, process improvements, and product changes.
- Review and approve Change Orders to ensure appropriate assessment of quality and regulatory impact.
- Partner with cross-functional teams and customers to support successful product development, commercialization, and continuous improvement initiatives.
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
- 2-5 years' experience in Quality Assurance or Quality Engineering in an FDA regulated industry
- Experience in process/equipment validation (Preferred)
- Background in biology and/or chemistry production processes a strong plus!
Starting Salary: $80,000 - $92,000 annually with consideration for relevant skills and 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 company contributions.
- 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
