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On Behalf of our client a medical device company, we are seeking for a Quality Engineer that will play a pivotal role in consolidating legacy CDG and LSG product risk management files.
Key responsibilities:

• Facilitating risk management assessments and updating risk plans and reports.
• Consolidating and updating product system hazard analysis files in accordance with company procedures and applicable standards.
• Coordinating meetings with cross-functional stakeholders to ensure completeness and accuracy of risk profiles, identifying new risks and hazards as necessary.
• Escalating events to management that require additional inputs or mitigations.
• Coordinating investigation activities among cross-functional subject matter experts.
• Reviewing and approving investigational documentation, ensuring complaint workflows are complete, and attaching required supporting documentation.
• Generating metrics reports monthly.
• Analyzing significant trends and coordinating mitigation efforts with subject matter experts.
• Presenting findings to complaint review boards and RAQA management.

Education and Requirements:

• Bachelor's degree or equivalent in a related technical or engineering discipline.
• 1+ years of experience or equivalent combination of education and experience.
• Basic knowledge and application of quality engineering principles and theories.
• Understanding of Medical Device/GMP/ISO regulations (ISO 14971, ISO 13485, MDSAP, FDA CFR Part 820), and FDA CFR Part 210/211 preferred.
• Basic understanding of risk management regulations, principles, and application.
• Veeva and SAP experience is a plus.
• Proficiency in Microsoft Office, Livelink, and Visio.

Please submit a copy of your resume in PDF or Word Format to be considered.