Quality Engineer

EXALTA Group; Bethlehem (Northampton County); On-site; USD 85,000 - 120,000; Full time

Job summary

EXALTA Group seeks a Quality Engineer - Strategic Customer to provide dedicated engineering support for a key strategic customer. You will own customer product quality, drive investigations, containment, and corrective actions while coordinating with Manufacturing, Engineering, and Quality teams across locations.

The role requires strong problem-solving, customer awareness, and the ability to drive actions across multiple functions and sites to meet customer requirements and quality targets.

Qualifications

• Bachelor’s degree in Engineering or related field; equivalent technical experience considered.
• 5+ years in Quality Engineering or Manufacturing Quality.
• Experience in medical device or other regulated/manufacturing environment preferred.
• Strong root cause analysis, CAPA, and problem-solving skills.
• Familiarity with MSA, Gauge R&R, statistics, and inspection methods.

Responsibilities

• Serve as the primary Quality Engineering point of contact for assigned customer products and quality-related activities.
• Develop a strong understanding of the customer's products, drawings, specifications, quality requirements, and expectations.
• Monitor customer quality performance, including complaints, nonconformances, escapes, returns, SCARs, and other quality indicators.
• Identify negative trends and emerging risks and initiate action before issues result in significant customer impact.
• Lead and support investigations into customer quality issues using structured root cause and problem-solving methodologies.
• Drive containment, root cause, corrective action, and effectiveness verification for customer-related quality issues.
• Ensure corrective actions address systemic causes across products, processes, and sites.
• Coordinate customer complaints, SCARs, CAPAs, and other quality actions to ensure technically sound responses within timelines.
• Partner with Manufacturing and Engineering to resolve recurring product and process quality issues.
• Review manufacturing and inspection data to identify process drift and recurring defects.
• Ensure inspection methods for customer products, support MSA, Gauge R&R, and correlation studies when needed.
• Support new product introductions, transfers, process changes, and other changes affecting customer products.
• Ensure customer-specific requirements are understood and incorporated into controls.
• Coordinate Quality activities across sites when products or processes span locations.
• Provide Quality input into proposed changes affecting the customer.
• Support customer communications with clear technical explanations of issues and actions.
• Maintain visibility of open customer quality actions and drive timely closure.
• Develop and maintain customer-specific quality metrics and report performance to leadership.
• Identify opportunities to proactively improve product quality and overall customer performance.

Skills

Root cause analysis

CAPA

Nonconformance

Statistical analysis

GD&T

Process validation

Cross-functional collaboration

Technical communication

Education

Bachelor's degree in Engineering

Equivalent relevant technical experience

Tools

MSA

Gauge R&R

FDA/ISO 13485 knowledge

Job description

Quality Engineer - Strategic Customer

Position Summary

The Quality Engineer - Strategic Customer is responsible for providing dedicated Quality Engineering support for one of the organization’s key strategic customers.

This role serves as the primary Quality Engineering focal point for the customer and provides end-to-end oversight of product quality and quality performance. The QE works cross-functionally with Manufacturing, Engineering, Quality Control, Supplier Quality, and Operations to identify and resolve quality issues, drive sustainable corrective actions, monitor performance, and ensure customer-specific quality requirements are effectively implemented.

The position requires strong technical problem-solving skills, urgency, customer awareness, and the ability to drive actions across multiple functions and manufacturing locations.

Key Responsibilities

• Serve as the primary Quality Engineering point of contact for assigned customer products and quality-related activities.
• Develop a strong understanding of the customer's products, drawings, specifications, quality requirements, and expectations.
• Monitor customer quality performance, including complaints, nonconformances, escapes, returns, SCARs, and other quality indicators.
• Identify negative trends and emerging risks and initiate action before issues result in significant customer impact.
• Lead and support investigations into customer quality issues using structured root cause and problem-solving methodologies.
• Drive containment, root cause, corrective action, and effectiveness verification for customer-related quality issues.
• Ensure corrective actions address systemic causes rather than individual events and are implemented across applicable products, processes, and sites.
• Coordinate customer complaints, SCARs, CAPAs, and other quality actions to ensure responses are technically sound, complete, and delivered within required timelines.
• Partner with Manufacturing and Engineering to resolve recurring product and process quality issues.
• Review manufacturing and inspection data to identify process drift, recurring defects, and opportunities for improvement.
• Ensure appropriate inspection and measurement methods are established for customer products and support MSA, Gauge R&R, correlation studies, and inspection method qualification when needed.
• Support new product introductions, product transfers, process changes, validation activities, and other changes affecting assigned customer products.
• Ensure customer-specific requirements are understood, documented, and appropriately incorporated into manufacturing and quality controls.
• Coordinate Quality activities across manufacturing sites when customer products or processes span multiple locations.
• Provide Quality input into proposed product, process, supplier, equipment, or inspection changes affecting the customer.
• Support customer communications by providing clear technical explanations of quality issues, investigations, containment, corrective actions, and improvement activities.
• Maintain visibility of open customer quality actions and drive cross-functional teams to timely closure.
• Develop and maintain customer-specific quality metrics and provide regular performance updates to Quality and Operations leadership.
• Identify opportunities to proactively improve product quality, process capability, inspection effectiveness, and overall customer performance.

Decision Authority

• Initiate containment when potential customer product risk is identified.
• Escalate significant product or process quality concerns.
• Initiate or recommend nonconformance, investigation, CAPA, or other quality actions.
• Recommend changes to manufacturing controls, inspection methods, measurement systems, and quality controls.
• Require appropriate technical investigation before closure of customer-related quality issues.
• Escalate overdue or ineffective corrective actions to Quality and Operations leadership.

Final approval for significant changes to established quality requirements, inspection strategies, product acceptance requirements, or QMS requirements remains with appropriate Quality leadership.

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing, or related technical discipline; equivalent relevant technical experience may be considered.
• 5+ years of Quality Engineering or Manufacturing Quality experience.
• Experience within medical device, aerospace, automotive, or another regulated/precision manufacturing environment strongly preferred.
• Strong experience with root cause analysis, CAPA, nonconformance, and structured problem solving.
• Experience with MSA, Gauge R&R, statistical analysis, and inspection methodology.
• Strong understanding of engineering drawings, specifications, tolerances, and GD&T.
• Knowledge of manufacturing processes and process validation.
• Working knowledge of ISO 13485 and FDA Quality System requirements preferred.
• Demonstrated ability to lead cross-functional problem solving and drive actions without direct authority.
• Strong written and verbal communication skills with the ability to communicate effectively with both customers and internal leadership.