Senior Quality Assurance Engineer

Job Title: Quality Assurance (QA) Engineer

Position Summary:

The QA Engineer is responsible for coordinating with suppliers, development, and manufacturing teams to support quality assurance activities. This includes contributing to the smooth transfer of designs to production and ensuring compliance with quality standards throughout the product lifecycle.

Key Responsibilities:

Supplier Relations & Issue Resolution

• Support processes related to supplier corrective actions and manage supplier-related quality issues.
• Resolve internal quality notifications, corrective actions, and complaint investigations associated with supplied parts.

Manufacturing & Process Support

• Provide ongoing support for process and design changes in manufacturing.
• Assist with design transfer and help maintain manufacturing documentation including records, process flows, and product specifications.

Material & Product Quality

• Investigate and address material nonconformities; participate in meetings to review material issues and coordinate follow-up with suppliers.
• Review incoming inspections of components and oversee disposition activities.
• Assess process, equipment, and material changes for validation needs.
• Develop and update risk management documentation in line with applicable standards.

Calibration & Documentation

• Help maintain the calibration system.
• Develop and update quality procedures, work instructions, and test methods.

Quality Systems & Compliance

• Ensure proper documentation to meet regulatory and quality system requirements.
• Lead investigations into quality issues and audit findings.
• Support corrective actions and initiatives to improve quality management systems.
• Assist with qualifying new suppliers and maintaining approved supplier lists.
• Participate in internal and supplier audits.

Problem Solving & Decision Making

• Use structured problem-solving techniques for root cause analysis and corrective action implementation.
• Make data-driven decisions and propose risk-based solutions.

Requirements:

Education & Experience

• Bachelor’s degree in engineering or a related technical discipline.
• 5–7 years of experience in manufacturing quality, preferably in regulated industries.
• Experience with process and test method validation, including Gauge R&R.
• Familiarity with risk management activities per industry standards.

Skills & Abilities

• Knowledge of advanced statistical approaches (e.g., hypothesis testing, design of experiments, ANOVA, measurement system analysis, capability studies, tolerance analysis, statistical power and sample size).
• Experience with supplier management and quality oversight preferred.
• Proficiency with statistical analysis software is preferred.
• Knowledge of quality system regulations and standards (e.g., 21 CFR 820, ISO 13485).
• Strong proficiency with Microsoft Office tools (Word, Excel).
• Hands-on experience with various manufacturing processes (such as assembly, ESD controls, cabling, clean room, labeling, sterilization).
• Strong writing skills for preparing and reviewing protocols and reports.
• Ability to analyze quality data and identify opportunities for process improvement.
• Start-up or cross-functional experience is a plus.

Location:

Hybrid work model with both onsite and remote requirements.