Senior Quality Assurance Engineer

Meissner • Camarillo, CA

3d

About The Position

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. Youll 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, its 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 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).

Requirements

• Bachelors 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 manufacturing or product development environment.
• Strong knowledge of QMS regulations and standards (e.g., cGMP) and thorough documentation and records compliance with industry and internal standards.
• Strong computer skills, including proficiency in word-processing, spreadsheets and databases.
• Proven experience in defining problems, collecting data, establishing facts, and drawing valid conclusions independently.
• Demonstrate strategic influence and confidence by guiding customers through complex decisions and process improvements with clarity, adapting to evolving business and technical contexts, and translating ambiguous requirements into strategic, customer-aligned recommendations.
• Serve as a role model for professionalism by coaching others, anticipating the broader impact of their decisions, and navigating ambiguity or conflict with poise and purpose.
• Actively reinforces a culture of accountability, optimism, conflict resolution, and thoughtful feedback.
• Advanced capacity of interpreting extensive variety of technical instructions in mathematical or diagram form and dealing with several abstract and concrete variables independently.
• Ability to clearly and effectively communicate, both verbally and in writing, to internal and external stakeholders.
• Respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Thorough project management experience 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.
• Works independently and cross-functionally in teams across the organization at a fast pace.
• Identify and manage challenges as they are presented and ability to de-escalate high tension projects and customer interactions.
• Excellent analytical skills; proven ability to lead initiatives with minimal supervision.
• Excellent attention to detail is necessary as our products are used in the production and use of life saving drugs.
• Some travel to client sites, including both domestic and international locations, may be required depending on project scope.

Nice To Haves

• Experience with Single-Use Systems, filtration, and injection molding are a plus.
• Experience with incorporating AI into processes is a plus.

Responsibilities

• 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).

Benefits

• 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
• Employee Assistance Program
• Paid Time Off, Paid Holidays, Anniversary Holiday

What This Job Offers

• Job Type: Full-time
• Career Level: Senior