Job SummaryThe Senior Quality Engineer is responsible for developing, maintaining, and improving the Quality Management System (QMS) and quality processes for precision electro-mechanical-optical products in an ISO 9001-certified manufacturing environment. This role partners closely with Engineering, Manufacturing, Supply Chain, and Operations to ensure product quality, process capability, regulatory compliance, and continuous improvement throughout the product lifecycle.
Responsible for collaborating with suppliers, development teams, and manufacturing teams to perform QA activities. This includes, but is not limited to, supporting new design and ensuring quality standards are met throughout the product lifecycle.
The ideal candidate has hands-on experience with complex laser systems, optical assemblies, and high-precision manufacturing processes, and is comfortable operating in a fast-paced, high-reliability production environment.
Key Responsibilities:- Customer Management
- Quality point of contact for customers
- Support customer SCAR processes.
- Handle track and manage internal NCMRs, CAPAs, and complaint corrective actions.
- Manufacturing & Process Support
- Lead investigations of nonconforming material, customer complaints, and field issues.
- Provide sustaining support for process improvements and design changes transitioning into manufacturing.
- Assist in design transfer activities and maintain manufacturing documentation (Validations, assembly drawings, procedures, DHRs, routers, BOMs, specifications).
- Support NRTL (National recognized testing laboratories) and other regulatory functions inspections and submissions.
- Develop and implement Stop Ship, Stop Build, and containment processes to effectively manage field risks.
- Material & Product Quality
- Investigate and disposition material nonconformances; participate in MRB meetings and follow up on supplier issues (Internal and external).
- Quality Systems & Compliance
- Maintain and continuously improve the ISO 9001-compliant Quality Management System
- Document activities in compliance with ISO-9000 standards and product regulatory regulations for compliance and safety.
- Lead investigations into quality issues, complaints, and audit findings.
- Support CAPA processes and promote QMS awareness and improvement initiatives.
- Create and modify quality systems documents related to process, risk, inspection and quality metric monitoring.
- Act as a subject matter expert on quality system requirements and best practices.
- Problem Solving & Decision Making
- Use root cause analysis and problem-solving tools to implement corrective actions.
- Make data-driven decisions and propose solutions based on calculated risks.
- Data Analytics and Reliability
- Extract, clean, and analyze quality-related data from manufacturing, testing, and service systems; develop dashboards and visual reports to identify trends, anomalies, and root causes.
- Define product quality and reliability requirements; design and execute qualification and reliability testing to enhance product robustness and MTBF.
- Utilize data analytics and advanced statistical methods to identify inefficiencies and drive improvements in product quality and reliability.
- Drive continuous improvement initiatives focused on defect reduction, yield improvement, and process capability.
- Support Lean, Six Sigma, and risk-based thinking initiatives.
- Mentor and guide junior quality engineers and inspectors as needed.
- Validation & Risk Assessment
- Evaluate proposed changes to processes, equipment, or materials for business, quality and customer impact.
- Lead the generation of DFMEA and PFMEA for products and processes.
- Generate and review process validation activities and report documentation (Control Plans, Process Flow Diagrams)
- Calibration & Documentation
- Assist with risk impact assessments for out-of-tolerance events.
- Develop and revise procedures, work instructions, and test methods.
- Education and Experience
- Bachelor's degree in engineering or a related technical field
- 5-7 years of manufacturing and quality experience within the Electro-mechanical equipment industry
- Optics experience
- Experience executing and creating manufacturing process documentation.
Required Skills and Abilities
- Experience with precision electro-mechanical or optical assemblies
- Working knowledge of statistical methods for data analysis
- Working knowledge of statistical software tools (e.g., Minitab) is preferred.
- Working knowledge of ISO-9001 design, development and manufacturing activities
- Strong proficiency in Microsoft Word and Excel
- Hands-on experience with manufacturing processes such as Electro-mechanical assembly, test, ESD controls and service depot activities
- Strong documentation skills for protocol, report generation and review
- Ability to analyze quality data and trends to identify improvement opportunities.
Key Competencies
- Attention to detail and strong analytical skills
- Structured problem solving and risk-based thinking
- Cross-functional leadership and influence
- Clear, professional communication
- Continuous improvement mindset
