Quality Engineer I

Responsibilities

• Support quality system elements including quality metrics, management reviews, risk management, and change management
• Author and manage Standard Operating Procedures (SOPs) and Work Instructions (WIs)
• Ensure compliance for the distribution, repackaging, relabeling, and containment of medical devices
• Define quality objectives for key performance indicators (KPIs) and monitor data for relevant trends
• Oversee quality management system activities, including Process Exceptions, Non-conformance, and CAPAs
• Support root cause analysis and validation or qualification tests for new equipment, processes, or software
• Act as the primary quality contact for 3PL clients to ensure established procedures for receiving, storage, and shipping are current

Requirements

• Bachelor’s degree (B.S.) in Engineering or a Science-related field
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, and Outlook)
• Strong analytical capabilities with the ability to evaluate reports, identify issues, and note trends
• Knowledge of quality control principles
• Ability to work independently and as part of a team in a fast-paced environment

Preferred Qualifications

• Experience in quality engineering within a manufacturing or logistics environment
• Knowledge of medical device regulations, specifically 21 CFR Part 820 or ISO 13485
• ASQ certifications (CQA, CQBA, CQE, CQM/OE) or Regulatory Affairs Professionals Society certification
• Working knowledge of electronic quality management systems (eQMS)
• Basic understanding of statistics

Benefits

• Comprehensive healthcare plans (medical, dental, and vision) starting on day one
• Educational assistance for approved collegiate programs
• Employer-paid life insurance and disability coverage
• 401(k) and Health Savings Account (HSA) options
• Paid leave including vacation, personal days, and parental leave
• Well-being programs including a Teammate Assistance Program (TAP) and Calm Health

About the Company

Owens & Minor is a global healthcare solutions company providing essential products, services, and technology solutions that support care delivery in leading hospitals, health systems, and research centers around the world. With over 140 years of experience and 14,000 teammates worldwide, we deliver comfort and confidence behind the scenes so healthcare stays at the forefront.