Are you passionate about precision and obsessed with improvement? Join us as an Advanced 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.

Who is Meissner?

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.

How you will make an impact:

The Advanced Quality Assurance Engineer ensures the quality of Meissner’s single-use systems and filtration products across the full product lifecycle. The role provides design and testing input, authors and reviews documentation, supports manufacturing, and plays an integral part in supporting pre and post-sales customer needs. The engineer leads and contributes to moderately complex and high impact quality initiatives to meet internal standards, customer requirements, and applicable regulations. They partner with Operations, Engineering, Manufacturing, Sales, Marketing, to build robust quality systems, perform risk assessments, and drive continuous improvement that strengthens product reliability and process capability. Success requires balancing technical depth, regulatory rigor, as well as customer focus and engagement

• Independently review product and application specifications; define the validation strategy and required documentation for manufacturing equipment and custom products (URS, DQ/IQ/OQ/PQ, risk assessments, test methods, and release criteria) in compliance with internal standard operating procedures (SOPs).
• Independently plan testing and validation (IQ/OQ/PQ) for products, processes, and advanced manufacturing systems; aid in defining acceptance criteria, perform DOE and statistical analysis, and author associated documentation.
• Lead internal and customer technical meetings and Quarterly Business Reviews (QBRs); present quality performance and drive agreed improvement actions with clear owners and timelines.
• Partner with Manufacturing engineering, Operations, and Production to support manufacturing escalations; facilitate structured problem solving (e.g., Ishikawa, 8D, etc.), drive rapid containment, root-cause analysis, and CAPA, and manage cross-functional communication to de-escalate and close issues with verified effectiveness.
• Lead simple to moderately complex complaints, post-sale investigations, and support customer escalations: perform root-cause analysis (5-Why/Ishikawa/8D) and failure analysis as needed; document investigations and CAPAs as per internal procedures; trend complaints; and manage written and verbal communications (status, interim/final responses, executive updates) to de-escalate and close with verified effectiveness.
• Partner with internal teams to assess, document, and execute internal and supplier based change control and customer notifications.

The skills and experience you’ll need:

• Bachelor's degree (B.S.) in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, Industrial Technology, Materials Engineering or equivalent technical discipline.
• 4+ years of progressive work experience in a regulated industry required. 2+ years of experience in quality engineering within a manufacturing or product development environment. Experience with Single-Use Systems, filtration, and injection molding are a plus.
• The ability to utilize basic computer skills is essential including the use of word-processing, spreadsheets, project management software and databases.
• Ability to define problems, collect data, establish facts, and draw valid conclusions independently. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables independently.
• Ability to clearly and effectively communicate, both verbally and in writing, to internal parties as well as those external to the organization, as this is a customer-facing role.
• The ability to define project timelines, identify the critical path and all necessary stakeholders, and drive projects to completion at or exceeding Quality standards and on time.
• The ability to work independently and cross-functionally in teams across the organization at a fast pace.

Don’t meet every single requirement? Apply anyway.

What we can offer you:

• Full Medical, Dental and Vision coverage with HSA Employer Contributions for eligible plans
• Additional Perks- HQ Onsite Full Gym, Ultramodern Coffee Bars, Free EV Charging Stations, Employee Discounts
• 401k, Profit Sharing, 401k Advisory Services
• Company Sponsored Life Insurance
• Employee Assistance Program
• Paid Time Off, Paid Holidays, Anniversary Holiday

Ready to make an impact? Let’s talk.

This position may require you to access information that is subject to U.S. export regulations. You may only access such information if you are a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. government.

Meissner is proud to be an Equal Opportunity Employer.

US BASE PAY SCALE $83,800 - $111,500

The base pay scale for this role is what Meissner reasonably expects to pay for the position although actual pay may vary from this scale depending on an applicant's experience.