What are the responsibilities and job description for the Senior Design Quality Engineer position at Meet Life Sciences?
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
- Tuition reimbursement
- Growth and promotion opportunities