Quality Engineer II

Overview

Quality Engineer II is responsible for supporting product quality, compliance, and continuous improvement initiatives within the organization. This role involves working cross-functionally to ensure that products, processes, and systems meet regulatory requirements, internal standards, and customer expectations. The Quality Engineer II contributes to sustaining quality systems, driving root cause investigations, and implementing corrective and preventive actions (CAPA).

Responsibilities

• Ensure compliance with applicable regulations, industry standards, and internal quality system requirements.
• Lead or support root cause analysis and implementation of effective corrective/preventive actions (CAPA).
• Support risk management activities, including Failure Mode and Effects Analysis (FMEA) and risk assessments.
• Collaborate with R&D, Manufacturing, and Supply Chain to ensure product quality throughout the lifecycle.
• Participate in product and process validations, including protocol development, execution, and report writing.
• Review and approve quality documentation such as change orders, validations, deviations, and non-conformances.
• Monitor and analyze quality metrics to identify trends and recommend process improvements.
• Support internal audits, supplier audits, and regulatory inspections.
• Provide training and guidance on quality system requirements to cross-functional teams.
• Drive continuous improvement initiatives to enhance product quality and operational efficiency.

Qualifications

Education: Bachelor's degree in Engineering, Science, or a related technical field.

Experience: 2-5 years of experience in quality engineering, regulatory compliance, or a related discipline (preferably in medical device, pharmaceutical, or other regulated industries).

Experience with quality systems such as ISO 13485, FDA 21 CFR Part 820, or similar standards.

Skills & Knowledge

• Strong knowledge of root cause analysis, CAPA, and problem-solving methodologies.
• Familiarity with statistical methods, process capability, and data analysis tools.
• Experience with validation (IQ, OQ, PQ), risk management, and document control.
• Proficiency in quality management systems (QMS) and electronic documentation tools.
• Excellent communication, collaboration, and technical writing skills.
• Strong organizational and time management abilities.

Preferred Qualifications

• Certification in quality (CQE, CQA, Six Sigma Green/Black Belt).
• Experience in medical device, pharmaceutical, or life sciences manufacturing.
• Knowledge of supplier quality management practices.
• Familiarity with lean manufacturing and continuous improvement methodologies.

Competencies

• Analytical and detail-oriented mindset.
• Ability to influence cross-functional teams without direct authority.
• Strong problem-solving and decision-making skills.
• Adaptability in a fast-paced, regulated environment.
• Commitment to quality, compliance, and customer satisfaction