Senior Design Quality Engineer

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

We’re hiring: Senior Design Quality Engineer

A leading life sciences manufacturing organization is seeking a Senior Design Quality Engineer to join its Manufacturing Science & Technology (MS&T) team. You’ll provide quality engineering leadership to technical development programs, new business programs, and customer-facing product development, embedding quality throughout the development lifecycle through Quality by Design (QbD) principles and Design of Experiments (DOE).

What you’ll do:

• 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

What you bring:

• 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

What we offer:

• Annual reviews and a company-wide incentive bonus
• Comprehensive medical, dental, and vision coverage, including an HSA option with company contributions
• Company-paid short-term disability, long-term disability, and life insurance
• Generous PTO, paid holidays, and paid family leave