Quality Assurance Engineer

EHOB INC•Indianapolis, IN

19h•Onsite

About The Position

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.

Requirements

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.
Proficiency in root cause analysis and corrective action (CAPA) processes.
Strong analytical and problem-solving skills.
Excellent verbal and written communication skills.
Ability to manage multiple projects and work in a fast-paced environment.
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.
Ability to work with mathematical concepts.
Ability to define problems, collect data, establish facts and draw valid conclusions.
Ability to interpret an extensive variety of information.
Knowledge of Microsoft Office Suite

Nice To Haves

Experience with MasterControl eQMS is a plus.
Certified Quality Engineer (CQE) or equivalent certification is a plus.
Familiarity with Six Sigma, Lean manufacturing, or other process improvement methodologies is a plus.
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.

Responsibilities

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