EHOB, Inc · 9 hours ago
Quality Assurance Engineer
Indianapolis, IN
Full-time
Onsite
Senior Level
$85K/yr - $100K/yr
5+ years expEHOB, Inc is seeking a Quality Assurance Engineer to support compliance with Corporate Quality and Environmental policies. The role involves providing leadership and guidance for Quality and Regulatory activities while assisting with quality and technical tasks.
Health CareMedical
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
Qualification
Required
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
Preferred
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
Company
EHOB, Inc
2020 IndyStar Top Workplace Recipient EHOB was founded in 1985, specializing solely in pressure injury prevention.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$0.11MKey Investors
RoundTable Healthcare PartnersIndiana Economic Development Corporation
2024-01-04Private Equity
2024-01-04Debt Financing
2022-06-20Grant· $0.11M
Leadership Team
Dan Quinn, MBA, CPA
Chief Financial Officer
James Bui
Chief Operating Officer
Recent News
2024-01-29
2024-01-29
Company data provided by crunchbase