Quality Manager

Responsibilities

• QMS Design & ISO 9001 Certification
• Design, implement, and maintain a QMS aligned with ISO 9001:2015 requirements
• Lead the company through initial ISO 9001 certification, including selection and management of the external certification body
• Own all QMS documentation: quality manual, SOPs, work instructions, forms, and records
• Conduct internal audits and manage corrective and preventive actions (CAPA)
• Facilitate management reviews and track quality objectives and KPIs
• Contract Manufacturer Quality
• Develop and manage supplier quality requirements for our contract manufacturing partner
• Conduct supplier audits and oversee non-conformance resolution
• Define incoming inspection criteria and acceptance standards for manufactured components and assemblies
• Design, Development, and Testing Controls
• Partner with the R&D and Product teams to establish design controls, change management processes, and design review frameworks
• Design and develop measurement system analysis requirements and processes
• Collaborate with teams and individuals to establish and implement testing plans, from unit component testing all the way to full system and software reliability and performance testing.
• Ensure traceability between customer requirements, design inputs, and verification/validation activities
• Cross-Functional Quality Culture
• Serve as the internal subject-matter expert on quality standards and best practices
• Train and support employees across the organization on QMS requirements and quality awareness
• Identify process improvement opportunities and drive continuous improvement initiatives

Requirements

• BS or MS in Mechanical Engineering or equivalent
• 10+ years of experience within Quality Assurance in a manufacturing or hardware product environment, including 3+ years in a supervisory role
• Prior quality management experience that includes a primary focus on measurement system analysis tools and frameworks
• Demonstrated experience leading or co-leading an ISO 9001 certification effort
• Strong working knowledge of QMS principles: document control, internal auditing, CAPA, risk-based thinking, and management review
• Experience working with contract manufacturers or external suppliers on quality requirements
• Experience working in a fast-moving, multidisciplinary environment with a high degree of ownership and technical independence
• Excellent written communication skills for policy and procedure documentation
• Strong communication skills and a practical, problem-solving mindset
• ISO 9001 Lead Auditor or Lead Implementer certification (ASQ CQM/CQA or equivalent a plus)
• Exposure to ISO 27001 and/or SOC 2 or other information management system standards
• Experience selecting and i

Additional Information

About SirenOpt SirenOpt helps manufacturers make better, safer, and more reliable micro- and nano-materials. These materials are the building blocks of critical sectors of the global economy such as batteries, computer chips, aircraft components, and power systems. But, surging material demand and growing complexity are pushing production to unprecedented scales and speeds, leaving manufacturers effectively flying blind. Small, undetected variations during production lead to wastage, lower performance, higher costs, and safety risks. SirenOpt is changing this. Our manufacturing intelligence platform scans materials, revealing critical internal information without damaging them. Using a novel combination of cold atmospheric plasma, physics-informed machine learning, and predictive analytics, SirenOpt creates unique, real-time fingerprints that capture material signals no other method can access. These insights give manufacturers unprecedented visibility into how materials behave as they are made. We turn hidden data into actionable intelligence to help manufacturers reduce variability and thus increase yield and performance. The technology can be deployed as a standalone tool or integrated directly into factory production lines. SirenOpt is currently deploying early versions of its platform with some of the largest industrial manufacturers in the world across North America, Europe, and Asia. Our first commercial product will be released in 2026. Role Overview SirenOpt is looking for a Quality Manager to lead the development and implementation of quality control systems. As our first dedicated Quality Manager, you will build and own our Quality Management System (QMS) from the ground up, lead us through ISO 9001 certification, and embed quality processes into the way we design, build, and deliver products. This is a hands-on, high-impact role for someone who enjoys working cross-functionally across an organization, solving hard problems quickly, and helping shape quality in a startup environment. You will be the quality leader within the company and support company goals and objectives while maintaining a strict adherence to ensuring the quality of incoming, intermediate, and outgoing materials.

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