Senior Strategic Quality Engineer for Key Customer

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

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.