Senior Design Quality Engineer — Lead Quality by Design

Lifecore Biomedical; Chaska (MN); On-site; USD 95,000 - 115,000; Full time

Benefits offered by this job

Learning & Growth opportunities

Annual incentive bonus

Health plans with HSA

Dental & Vision insurance

Disability & Life Insurance

Paid time off

Holidays & personal days

Family leave

Tuition reimbursement

401k matching

Job summary

Lifecore Biomedical in Chaska, MN, seeks a Senior Design Quality Engineer to lead quality engineering across development programs and customer-facing product activities, partnering with cross-functional teams to embed Quality by Design throughout the lifecycle.

You will guide validation strategies for clinical and commercial products, ensure adherence to design controls and regulatory requirements, and support robust process development and transfer.

Qualifications

• BS in Engineering or Life Sciences required.
• 5-8 years of quality assurance or quality engineering experience in the medical device or pharmaceutical industry.
• Quality engineering support experience for process improvement or process development.
• Experience in process/equipment validation.
• Comprehensive understanding of GMP regulations for medical devices, pharmaceutical products and active pharmaceutical ingredients.
• In-depth understanding of design control and regulatory requirements for process design and transfer.
• In-depth understanding of current good manufacturing practices (cGMP) and related regulatory concerns.

Responsibilities

• Provide quality engineering leadership to development programs, new business programs, and customer-facing product development activities.
• Ensure validation strategies for clinical and commercial products are developed and executed in compliance with regulatory requirements.
• Ensure development programs comply with the Quality System and all Design Control requirements.
• Apply quality engineering concepts to monitor and review process development efforts.
• Review and approve experimental plans, development processes, equipment qualification and controlled documentation.
• Mentor experimental technique and statistical/technical data analysis.
• Ensure data review and trend analysis to support robust process quality.
• Provide guidance in the structure of product development process documentation.

Skills

Quality engineering experience

Process improvement

Design of Experiments

Regulatory knowledge (GMP, cGMP)

Statistical data analysis

Quality by Design (QbD)

Education

BS in Engineering or Life Sciences

Job description

Lifecore Biomedical in Chaska, MN, seeks a Senior Design Quality Engineer to lead quality engineering across development programs and customer-facing product activities, partnering with cross-functional teams to embed Quality by Design throughout the lifecycle.

You will guide validation strategies for clinical and commercial products, ensure adherence to design controls and regulatory requirements, and support robust process development and transfer.