Quality Assurance Engineer

Summary

The Quality Assurance Engineer will support the organization towards compliance of Corporate Quality and Environmental policies, provide leadership, expertise, and guidance for all Quality and Regulatory activities, and assist with required quality and technical tasks.

Essential Duties and Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Ensure compliance with FDA, ISO 13485, and other relevant regulatory standards for medical device manufacturing.
• Develop and implement quality management system documents for product design, development, and manufacturing.
• Conduct internal and external audits of quality systems to ensure adherence to quality standards.
• Coordinate the activities for Quality Management System (QMS) review and present the supporting data and metrics
• Review and approve manufacturing process changes impacting product quality, including changes to equipment and software
• Participate in risk management activities (FMEA, risk analysis) to identify potential product risks and implement corrective actions.
• Manage non-conformances, CAPA (Corrective and Preventive Action) processes, and root cause analysis.
• Collaborate on the investigations of customer complaints, ensure timely and accurate closure and issue reports back to affected customers.
• Work with cross-functional teams to resolve quality issues, including R&D, manufacturing, and regulatory departments.
• Develop and maintain quality documentation, including process validation protocols, technical reports, and device history records.
• Monitor and analyze quality data to identify trends and drive continuous improvement initiatives.
• Co-lead with R&D and Manufacturing Engineering the product, process and software validation activities (IQ, OQ, PQ) to ensure the product meets the required specifications.
• Co-lead with Sourcing the supplier qualification process and conduct regular audits to ensure that supplied components and raw materials meet quality requirements.
• Manage SCAR (Supplier Corrective Action Request) process to address and resolve quality issues arising from suppliers.
• Provide the tools and training on quality systems and procedures for internal teams.
• Ensure proper calibration and maintenance of quality inspection equipment.
• Other duties as assigned

Education and/or Experience

• Bachelor's degree in engineering (Mechanical, Electrical, Computer, Biomedical, Industrial, or related field) or equivalent experience.
• 5+ years of experience in quality assurance/quality engineering in a medical device or related industry.
• Strong understanding of regulatory requirements, including FDA 21 CFR 820, ISO 13485
• Experience with quality management systems, audits, and compliance.
• Experience with MasterControl eQMS is a plus.
• Proficiency in root cause analysis and corrective action (CAPA) processes.
• Strong analytical and problem-solving skills.
• Excellent verbal and written communication skills.
• Certified Quality Engineer (CQE) or equivalent certification is a plus.
• Familiarity with Six Sigma, Lean manufacturing, or other process improvement methodologies is a plus.
• Ability to manage multiple projects and work in a fast-paced environment.
• Knowledge of statistical process control (SPC) and other quality control tools is a plus.
• Proficiency in quality-related software tools (e.g., Minitab, QMS systems) is a plus.

Other Skills

• Language skills: Ability to read, analyze, and interpret the most complex documents. Ability to respond effectively to the most sensitive inquiries or complaints. Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public group, and/or boards of directors.
• Mathematical skills: Ability to work with mathematical concepts.
• Reasoning: Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of information.
• Computer skills: Knowledge of Microsoft Office Suite

Competencies

• Communication: Effectively communicate to internal and external business partners by sharing expertise to encourage accomplishment of shared business goals.
• Teamwork and Collaboration: Actively support and collaborate with peers and team members to contribute to overall company success.
• Knowledge: Display knowledge of department, applicable products, services and business objectives. Demonstrate a continuous learning mindset through continued professional and personal development.
• Accountability: Follow through with tasks and responsibilities in an appropriate and timely manner.
• Work Quality: Produces results, meets goals, and provides services that meet or exceed EHOB's standards.
• Adaptability: Readily and effectively adapts way of working, thinking and acting in response to changing workplace conditions, targets or goals.
• Strategic Thinking: Demonstrate ability to understand a situation or obstacle from all perspectives.
• EHOB Ambassador: Reflect EHOB's mission, vision and values.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; risk of electrical shock; risk of radiation and vibration. The noise level in the work environment is usually moderate.

EHOB does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status or military service.