Quality Assurance Engineer II

Merit Medical Systems, Inc. • South Jordan, UT

103d

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 providing routine and complex quality systems work for CAPAs and Internal Audits, including managing CAPA records, conducting internal audits, and optimizing quality systems.

Requirements

• Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field with three years quality engineering experience.
• Strong interpersonal, organizational, and verbal and written communication skills.
• Demonstrated working knowledge of 21 CFR 820, ISO 13485, ISO14791, and other medical device related standards.
• Proven ability to work effectively in a team environment through conflict resolution and negotiations.
• Working knowledge of statistical methodologies, quality control and manufacturing tools.
• Demonstrated computer skills preferably in spreadsheets, word processing, database and other applicable software programs.

Nice To Haves

• Medical device experience or equivalent experience in a regulated industry.
• Experience with Master Control, Oracle and DOMO.
• Experience handling Internal Audits Issues and CAPAs.
• Certified Internal Auditor or Lead Auditor for ISO13485.

Responsibilities

• Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.
• Evaluate and ensure the timely completion of CAPA system activities throughout the lifecycle of the CAPA.
• Facilitate the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance.
• Support the attainment of CAPA goals and objectives, prepares metrics for Management Review.
• Coordinate CAPA Board Management reviews.
• Conduct internal audits and facilitate the Internal audit program.
• Lead and perform on-site quality management system (QMS) internal audits to ensure compliance with internal and regulatory requirements.
• Prepare and support third party audits (Supplier, FDA, EU Notified bodies) in the front and back room.
• Independently evaluate, select, and apply standard engineering techniques, procedures, and criteria.
• Review, approve and generate Engineering Change Notifications (ECNs) to update or generate verification, validation, monitoring and inspection methods.
• Review nonconformance records to determine disposition, root cause and need for corrective and preventive actions.
• Ensure containment of nonconforming product has been performed.
• Identify and implement changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system.
• 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 (2) Onsite Cafeterias.
• Employee Garden | Gardening Classes.
• 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays.
• 401K | Health Savings Account.

What This Job Offers

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