Senior Design Quality Engineer: Impact, Growth, PTO

Meet Life Sciences Ltd.; Chaska (MN); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Annual incentive bonus

Comprehensive medical, dental, and vis

HSA option with company contributions

Company-paid disability and life insur

Generous PTO & holidays

Job summary

Meet Life Sciences Ltd. in Minnesota seeks a Senior Design Quality Engineer to lead quality engineering across development programs within MS&T.

You will embed quality by design principles and drive DOE-driven process development and validation strategies for clinical and commercial products. The role requires deep GMP/cGMP knowledge, experience in design control, and mentoring teams on experimental techniques and data analysis to ensure robust product quality and compliant documentation

Qualifications

• BS in Engineering or Life Sciences.
• 5-8 years of quality assurance or quality engineering experience in the medical device or pharmaceutical industry.
• Quality engineering support experience in process improvement or process development.
• Experience in process/equipment validation.
• Strong understanding of GMP/cGMP regulations for medical devices, pharmaceutical products, and APIs.
• Solid knowledge of experimental statistics and DOE.
• In-depth understanding of design control and regulatory requirements for process design and transfer.

Responsibilities

• Provide quality oversight and stay current on industry best practices for process development.
• 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 Design Control requirements.
• Review and approve experimental plans, development processes, equipment/process qualification, and controlled documentation.
• Mentor teams on good experimental technique and statistical/technical data analysis.
• Review data and investigate trends to ensure robust process quality.
• Guide the structure of product development process documentation.

Skills

Quality engineering

DOE

Statistical analysis

Process improvement

Regulatory knowledge

Education

BS in Engineering or Life Sciences

Job description

Meet Life Sciences Ltd. in Minnesota seeks a Senior Design Quality Engineer to lead quality engineering across development programs within MS&T.

You will embed quality by design principles and drive DOE-driven process development and validation strategies for clinical and commercial products. The role requires deep GMP/cGMP knowledge, experience in design control, and mentoring teams on experimental techniques and data analysis to ensure robust product quality and compliant documentation