Meissner · 3 weeks ago
Senior Quality Assurance Engineer
Camarillo, CA
Full-time
Onsite
Mid, Senior Level
$101K/yr - $125K/yr
5+ years expMeissner is a company dedicated to the development of lifesaving and life enhancing drugs, therapies, and vaccines. The Senior Quality Assurance Engineer will lead quality initiatives, ensuring compliance with internal standards and regulatory guidelines while partnering cross-functionally to enhance product reliability and process capability.
Food and BeverageHealth CareManufacturingPharmaceuticalTelecommunications
No H1B
U.S. Citizen Only
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)
Qualification
Required
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 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
Preferred
Experience with Single-Use Systems, filtration, and injection molding are a plus
Experience with incorporating AI into processes is a plus
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
Company Sponsored Life Insurance
Employee Assistance Program
Paid Time Off, Paid Holidays, Anniversary Holiday
Company
Meissner
Meissner manufactures advanced microfiltration products and One-Touch® single-use systems for critical applications.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Max Blomberg
Chief Operating Officer
Recent News
Research & Development World
2025-08-17
2024-04-29
2023-04-11
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