Quality Engineer

Position Overview

We are seeking a skilled Quality Engineer to enhance quality management and maintain regulatory compliance within a medical device manufacturing setting. This role is instrumental in guaranteeing product standards, fostering ongoing improvements, and adhering to relevant industry and regulatory frameworks.

The selected candidate will collaborate with teams across Engineering, Manufacturing, Supply Chain, and Operations to facilitate new product launches, process enhancements, validation procedures, and quality system initiatives. This position demands a proactive problem-solving mindset, effective risk management, and quality assurance throughout the product lifecycle.

Key Responsibilities

• Ensure alignment with quality regulations and standards such as ISO 13485 and FDA requirements.
• Assist with regulatory audits, certification processes, customer inspections, and internal quality assessments.
• Engage in supplier quality management including conducting assessments and audits when necessary.
• Act as a quality liaison for stakeholders, clients, and external partners.
• Evaluate engineering documents, product specifications, and design records for compliance and quality assurance.
• Contribute to planning and implementing verification, validation, and qualification activities.
• Support risk management processes based on industry best practices.
• Create and update quality plans, validation reports, and related documentation.
• Investigate quality concerns and nonconformities, performing root cause analysis and fostering corrective and preventive measures.
• Participate in failure analyses, complaint resolution, deviation handling, and material review.
• Monitor and analyze quality metrics to identify areas for product and process enhancement.
• Maintain proper document control and ensure quality records adhere to procedural standards.
• Drive continuous improvement initiatives aimed at operational efficiency and product dependability.
• Perform additional duties and special projects as assigned.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or related technical fields.
• Minimum of 5 years’ experience in quality engineering or assurance within a regulated medical device manufacturing environment.
• Deep understanding of ISO 13485, FDA Quality System Regulations, and device quality management standards.
• Hands-on experience with CAPA, nonconformance management, risk assessments, audits, and validation tasks.
• Proficient in risk management methodologies including ISO 14971.
• Strong analytical thinking, problem-solving abilities, and effective communication skills.
• Capacity to collaborate across diverse functional teams in a fast-paced manufacturing environment.

Preferred Qualifications

• Familiarity with Class I, II, or III medical device quality support.
• Experience with customer-facing quality roles.
• ASQ certifications such as CQE or CQA are advantageous.
• Exposure to supplier quality management and new product introduction processes.