Senior Quality Assurance Engineer

Are you passionate about precision and obsessed with improvement? Join us as a Senior Quality Assurance Engineer and play a key role in delivering exceptional products that exceed customer expectations. You’ll drive quality initiatives, partner cross-functionally, and set the standard for operational excellence.

The goal at Meissner is to be more than simply good; it is to be extraordinary. Extraordinary performance comes from extraordinary people.

Meissner as a group is passionate about helping our clients manufacture lifesaving and life enhancing drugs, therapies, and vaccines. We develop, manufacture, supply and service advanced microfiltration products and single-use systems worldwide.

We know that when you are passionate about what you do, it’s more than just a job.

Meissner is focused on the development of the whole individual, and we have programs and tools in place to help us stay at our best mentally and physically. In alignment with our commitment to support the growth and development of the whole individual, Meissner has inaugurated a Learning and Development department to solely focus on cultivating our team. When you grow, we grow.

The Senior Quality Assurance Engineer leads and supports quality initiatives to ensure compliance with internal standards, customer requirements, and applicable regulatory guidelines. This role partners cross-functionally with Operations, Engineering, Manufacturing, Sales and Marketing to develop and implement quality systems, perform risk assessments, and drive continuous improvement initiatives that strengthen product reliability and process capability. The Senior Quality Assurance Engineer leads complex projects independently and interfaces with customers.

• Lead quality activities for process changes and new product introductions.
• Author, review, and execute Validations (Installation Qualification (IQ)), Operational Qualification (OQ), and Process Performance Qualification (PPQ) and Qualifications for equipment, systems, products and processes.
• Manage multi-departmental projects to ensure that initiatives and specifications are satisfied, timelines are adhered to, associated cost targets are achieved, etc.
• Independently conduct root cause analysis and implement corrective and preventive actions (CAPA) for internal and customer issues, as applicable.
• Develop and update SOPs and DOEs (including new test procedures).
• Assist with deviation or excursion responses, testing and analysis, etc.
• Support, identify, and often lead continuous quality improvement, efficiency and lean manufacturing initiatives throughout the organization.
• Support internal and external audits, ensuring compliance with applicable quality standards.
• Provide training and training materials to colleagues within the team and within other departments as an SME in multiple areas.
• Lead internal and external customer discussions and present Meissner capabilities and solutions, providing pre- and post-Sales customer technical support.
• Mentor and provide technical guidance to QA engineers and technicians.
• Ensure documentation and quality records meet regulatory and company requirements.
• Partner with design and process engineering teams to ensure manufacturability and quality are built into the product.
• Collaborate with AE, Planning and Procurement to establish incoming quality requirements and improve supplier performance.
• Interface with and offer continuous improvement support for the MES/ERP systems.
• Ensure quality system compliance across product receipt, handling, processing, and distribution processes.
• Support product lifecycle activities through quality engineering best practices.
• Collaborate with other departments and senior leadership to generate relevant technical content (e.g., Qualification Guides, Specification Sheets, Technical Bulletins, Training Guides).

• Bachelor’s degree (B.S.) in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, Industrial Technology, Materials Engineering or equivalent technical discipline required.
• 5+ years of experience in quality engineering within a…