Quality Assurance Engineer I

Merit Medical Systems • Richmond, VA

77d

About The Position

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world. The position involves performing routine quality engineering work for specific product lines under general supervision and guidelines, including failure investigation, oversight of nonconforming materials, conducting risk analysis, defining quality inspection plans, and optimizing quality systems.

Requirements

• Education equivalent to a Bachelor's Degree in Quality Engineering or related field, or a Master's Degree.
• Strong interpersonal, organizational, and communication skills.
• Demonstrated knowledge of 21 CFR 820, ISO 13485, ISO 14791, and other medical device standards.
• Proven ability to work effectively in a team environment.
• Working knowledge of statistical methodologies and quality control tools.
• Demonstrated computer skills in spreadsheets, word processing, and databases.

Nice To Haves

• Medical device experience or equivalent in a regulated industry.
• Experience with SmartCAPA, Oracle, and Crystal Reports.
• Experience handling deviations, investigations, and CAPAs.

Responsibilities

• Perform routine engineering work requiring the application of standard techniques, procedures, and criteria.
• Use discretionary judgment in making decisions regarding engineering alternatives.
• Perform higher technical level work for training purposes, ensuring correct application of scientific principles.
• Responsible for risk management documentation for assigned product lines or processes.
• Review, approve, and generate Engineering Change Notifications (ECNs) for verification, validation, and inspection methods.
• Evaluate and participate in the selection of suppliers by monitoring performance and conducting audits.
• Review nonconformance records to determine disposition, root cause, and corrective actions.
• Ensure containment of nonconforming product to prevent unintended use.
• Identify and implement changes to maintain the effectiveness of the quality management system.
• Evaluate the manufacturing environment for adequate controls and safety.
• Participate in design and development activities as needed.
• Perform other related duties and tasks as required.

Benefits

• Multiple shifts and hours to choose from: Days, Swing (Eve), and Nights.
• Medical/Dental & Other Insurances (eligible the first of month after 30 days).
• Low Cost Onsite Medical Clinic.
• Two Onsite Cafeterias.
• Employee Garden and Gardening Classes.
• 3 Weeks' Vacation, 1 Week Sick-Time, Paid Holidays.
• 401K and Health Savings Account.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees