Quality Engineer II (QE II)
3 days ago
Valencia
Job DescriptionJob Overview The Quality Engineer II (QE II) ensures medical devices and related processes comply with FDA regulations, ISO 13485, and applicable international standards. This mid-level role independently leads core quality activities, including nonconformance investigations, CAPA execution, risk management support, and manufacturing quality support. The QE II leads moderate-scale quality projects, mentors junior team members, and collaborates cross-functionally with R&D, Manufacturing, Supplier Quality, and Regulatory Affairs to drive product quality and continuous improvement. Key Responsibilities • Independently support and maintain the Quality Management System (QMS) in compliance with FDA 21 CFR Part 820, ISO 13485, and internal procedures, • Lead quality engineering activities for moderate-scale new product development projects, including documentation support, design reviews, design transfer and verification and validation efforts, to ensure compliance with medical device regulatory requirements., • Contribute to design control activities including design reviews and design transfer to manufacturing, • Author, review, and approve SOPs, work instructions, and quality records, • Participate in internal audits, supplier audits, and regulatory inspections; lead audit responses as assigned, • Lead quality investigations, including nonconformance reports (NCRs) and Corrective and Preventive Actions (CAPAs), to identify root causes and implement effective solutions, • Perform root cause analysis using tools such as 5 Whys, Fishbone, FMEA, and basic statistical methods, • Ensure compliance with ISO and applicable industry standards through effective quality system execution and oversight, • Implement and support process improvements to enhance product quality, compliance, and operational efficiency, • Support complaint handling review and post-market surveillance activities, • Support design verification and validation activities to ensure products meet design inputs, regulatory requirements, and intended use, • Provide day-to-day quality engineering support to manufacturing and operations, • Review and approve Device History Records (DHRs), batch records, and inspection results, • Lead Material Review Board (MRB) activities, including disposition of nonconforming material, • Support process changes through change control and risk assessment, • Apply deep knowledge of PPAP (Production Part Approval Process), APQP (Advanced Product Quality Planning), and process/validation activities to ensure product and process quality, • Perform advanced statistical analysis of quality and manufacturing data to identify trends, root causes, and improvement opportunities, • Lead supplier quality management activities, including qualification, audits, certificates performance monitoring, and corrective action oversight, • Review supplier documentation, certifications, and quality agreements, • Lead or support validation activities (IQ/OQ/PQ) for manufacturing processes, equipment, and software, • Support product and process risk management activities in accordance with STD-197 ISO 24971 - Medical Devices - Guidance on the application of ISO 14971, • Serve as a quality representative with cross-functional teams, • Mentor and provide guidance to Quality Engineer I or quality inspectors as needed, • Analyze quality data and trends to identify improvement opportunities, • Support or lead continuous improvement projects using Lean or basic Six Sigma tools, • Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable international standards., • Experience with design controls, risk management, verification/validation, and CAPA processes., • Strong problem-solving, communication, and project management skills., • Ability to work independently, lead, mentor, and coordinate with cross-functional teams on quality initiatives and projects, • Strong risk-based and data-driven decision-making skills to resolve quality issues and implement improvements, • Excellent verbal and written communication skills for conveying technical and regulatory information to stakeholders at all levels, • Works effectively in cross-functional teams and influences outcomes without direct authority, • Good understanding of industry practices, • Proficient with tools, systems, and procedures, • Basic planning/organizational skills and techniques, • Good decision making, analysis and problem solving skills with ability to multi-task, • Good verbal and written communication skills, • Good presentation and public speaking skills, • Good interpersonal skills, • Basic conflict resolution skills Travel/ Physical Demands Travel required typically 20%. Office environment. No special physical demands required. Scope Advanced intermediate level professional; knowledge within own discipline and developing basic knowledge of organization, processes and customers. Good judgment, sound analytical ability, evaluation, originality and ingenuity required to perform tasks. Frequently apply the fundamental concepts, practices, and procedures of a particular field. Apply company policies and procedures to resolve a variety of routine and non-routine issues. Complexity Work on problems of moderate scope and impact where analysis of situations or data requires a review of a variety of factors. Analyze possible solutions using standard procedures to solve a range of straightforward problems; may recommend solutions to business challenges. Demonstrate good judgment within defined procedures and practices for obtaining solutions. Build productive internal/external working relationships. Supervision Receive a moderate level of instruction on day-to-day work and general instruction on new projects or assignments. Assignments can be broad in nature. Performance Requirements Typically, to advance to a new job level, employees must demonstrate professional behavior and should consistently be at the high-end of meets expectations or consistently exceed expectations. TriMed, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.