Description
About the Role
Our client is seeking a Quality Engineer to support and strengthen their Quality Management System (QMS) in alignment with FDA Quality System Regulations, ISO 13485, and other applicable industry standards. This individual will play a key role in ensuring compliance, supporting audits, and collaborating with cross-functional teams during the design and validation phases of medical device development. The ideal candidate has a strong understanding of regulatory requirements, excellent problem-solving skills, and a proactive approach to maintaining quality excellence.
Key Responsibilities
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Ensure compliance with ISO 13485, 21 CFR Part 820, and internal Quality System requirements.
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Support audits conducted by regulatory agencies, Notified Bodies, and customers.
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Participate in supplier audits as required.
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Serve as the primary quality interface for assigned customers and suppliers.
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Review design input specifications and design documentation for new product development.
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Assist with planning, developing, and executing product verification and validation protocols.
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Conduct risk analyses for both new and existing products per ISO 14971 standards.
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Develop Quality Plans and Master Validation Plans to support product implementation.
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Support ongoing product and process quality activities, including NCRs, MRBs, deviations, root cause analysis, and CAPA.
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Manage customer deliverables and ensure all quality documentation reaches approved/released status.
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Perform other related quality and compliance tasks as assigned.
Qualifications
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Education: Bachelor’s Degree in Engineering, Quality Assurance, or a related discipline.
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Experience: Minimum of 1 year in medical device quality assurance.
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Knowledge:
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Working understanding of ISO 13485 and FDA QSR for Class I, II, and III medical devices.
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Strong grasp of ISO 14971 Risk Management principles.
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Skills:
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Proficiency in quality management software, statistical tools, and Microsoft Office Suite.
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Skilled in root cause analysis methods (Fishbone, 5 Whys, etc.).
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Excellent written and verbal communication abilities.
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Strong time management and organizational skills.
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Preferred Qualifications
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5+ years of experience in medical device quality assurance.
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ASQ Certification (CQE, CQA, or equivalent) preferred.
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Familiarity with sterilization validation (ISO 11135, ISO 17665).
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Understanding of cleanroom certification and monitoring under ISO 14644.