Quality Engineer

Job Title:

Quality Engineer Job Description

The Quality Engineer plays a key role in ensuring robust manufacturing quality and regulatory compliance in an electronics and medical device environment. Approximately 60% of the role focuses on technical activities such as audit preparation, root cause analysis (RCA), corrective and preventive actions (CAPA), first pass yield improvement, and continuous improvement initiatives. The remaining 40% is more strategic, involving data analysis, quality management system (QMS) audits, and validation activities to drive long-term quality performance and process excellence.

• Oversee in-process quality controls and day-to-day quality performance in manufacturing, including metrics such as defects per million opportunities (DPMO), material review board (MRB) activities, and continuous improvement using systematic approaches.
• Remain readily available on the manufacturing floor to resolve real-time quality issues and support production teams in maintaining high-quality output.
• Manage the complaint and nonconformance (NCR) database and address customer-issued supplier corrective action requests (SCARs) in a timely and thorough manner.
• Perform product and process qualifications based on customer requirements, ensuring compliance with relevant standards and specifications.
• Support the new product introduction (NPI) process for new products, contributing to quality planning, risk assessment, and validation activities.
• Develop customer-specific quality plans that align with contractual requirements, regulatory expectations, and internal quality standards.
• Support the Site Quality Leader in regulatory, customer, and internal audits by preparing documentation, participating in audit activities, and implementing follow-up actions.
• Execute the internal quality audit program and ensure findings are documented, communicated, and closed through effective corrective and preventive actions.
• Lead and train cross-functional teams to perform layered process audits, promoting a culture of accountability and continuous improvement.
• Assist the Site Quality Leader in maintaining and improving the QMS, ensuring procedures, work instructions, and records remain current and effective.
• Ensure conformance to quality and environmental certifications and standards, such as ISO and IPC, by monitoring compliance and supporting related initiatives.
• Coordinate with the Regional Supplier Quality Engineer to resolve supplier performance issues, including quality defects, delivery concerns, and process nonconformances.
• Support training needs by providing guidance and coaching to quality and production team members on quality tools, standards, and best practices.
• Coordinate and conduct frequent cell-level layered process audits with quality engineering personnel and other site functional leaders to verify process adherence and effectiveness.
• Assist with regional and site quality initiative projects, contributing technical expertise and data-driven insights.
• Support and assist other Quality Engineers in customer-focused teams to address systemic issues and drive effective CAPA resolution.
• Manage and collect systemic data for process improvement, using analytical tools to identify trends, root causes, and opportunities for optimization.
• Maintain up-to-date knowledge of quality and regulatory changes applicable to the manufacturing site and communicate relevant updates to stakeholders.
• Keep the Site Quality Leader fully informed of significant occurrences and trends that impact process quality, quality systems, or supplier quality operations.
• Drive continuous improvement and first pass yield enhancement through structured methodologies such as Kaizen and other CI efforts.
• Prepare for and participate in customer, regulatory, and third-party audits, ensuring readiness of documentation, processes, and personnel.

• Bachelor's degree in Quality, Engineering, or equivalent industry and/or military experience.
• Up to 4 years of experience in quality or related roles, preferably within electronics manufacturing services or a related contract manufacturing environment.
• Hands-on experience in electronics manufacturing, particularly PCB and PCBA assembly.
• Background in medical devices and familiarity with associated regulatory and quality requirements.
• Experience working in quality for an organization certified to ISO standards, with ISO 9001 experience preferred.
• Proven experience with audits, root cause analysis (RCA), and corrective and preventive actions (CAPA).
• Knowledge of AS9100 requirements and their application in manufacturing quality systems.
• Familiarity with IQ, OQ, and PQ qualification processes for equipment and processes.
• Basic knowledge and understanding of Lean and Six Sigma or other process improvement methodologies.
• Ability to use quality tools such as Pareto charts, histograms, statistical process control (SPC), and flowcharts.
• Familiarity with PFMEA, control plans, measurement system analysis, APQP, and…