Quality Engineer

Responsibilities:

• Develop, implement, and continuously improve quality policies, procedures, and systems in accordance with ISO 13485, applicable GMP/GDP requirements, and 21 CFR Part 820 .
• Lead and manage CAPA activities from initiation through effectiveness verification , ensuring timely and sustainable resolution of quality issues.
• Facilitate structured root cause investigations using appropriate problem-solving methodologies and drive cross-functional corrective and preventive actions.
• Develop, review, and execute validation strategies and protocols for equipment, processes, software, and test methods , including IQ/OQ/PQ activities.
• Apply statistical tools and data analysis to identify trends, assess process capability, monitor quality performance, and support data-driven decision-making.
• Apply risk management, FMEA, SPC, and other quality engineering methodologies to identify and mitigate manufacturing and product risks.
• Support new product development, design transfer, process development, and manufacturing transfer activities from a quality engineering perspective.
• Partner with Manufacturing and Engineering to identify opportunities for process optimization, defect reduction, and continuous improvement.
• Support the development and monitoring of quality metrics and site KPIs; identify trends and recommend appropriate actions.
• Participate in and support internal, supplier, and third-party regulatory audits , including preparation, response, and follow-up activities.
• Provide Quality input into nonconformances, deviations, complaints, change controls, and other quality system processes.
• Support Management Review activities through data analysis, reporting, and presentation of quality performance.
• Develop and deliver training on quality systems, procedures, problem-solving methodologies, and regulatory requirements.
• Mentor and provide technical guidance to other members of the Quality organization.
• Maintain strong documentation practices and ensure quality records are accurate, complete, and compliant.
• Take on additional quality engineering projects and initiatives as the organization continues to grow.

Qualifications:

• Bachelor's degree in Engineering, Science, or a related technical discipline , or equivalent combination of education and experience.
• 3–4+ years of Quality Engineering experience , preferably within the medical device or other regulated manufacturing industry .
• Hands-on experience managing CAPA activities from investigation through implementation and effectiveness checks .
• Experience developing, reviewing, and/or executing IQ/OQ/PQ protocols .
• Working knowledge of ISO 13485, 21 CFR Part 820, GMP, and GDP requirements.
• Experience with root cause analysis and structured problem-solving methodologies .
• Strong understanding of quality systems, manufacturing processes, and quality engineering principles.
• Strong analytical, organizational, and problem-solving skills with the ability to manage multiple priorities in a fast-paced environment.
• Excellent written and verbal communication skills, with the ability to communicate effectively with technical teams, operators, management, and external auditors.
• Ability to work independently while collaborating effectively across Engineering, Manufacturing, Operations, Regulatory, and Quality functions.
• Demonstrated ability to influence others and drive projects to completion without relying solely on direct authority.