IQA Engineer - Medical Device Quality

About the role

Merit Medical, a medical device company, is hiring an IQA Engineer. The role covers quality assurance and risk management documentation for assigned product lines, including ECNs, supplier evaluation and nonconformance review. The shift is 8:00am to 5:30pm Monday to Friday.

Key responsibilities

• Perform routine engineering work using standard techniques and procedures, with limited discretionary judgment.
• Produce risk management documentation and identify and update failure modes, leading teams to implement improvements.
• Review, approve and generate Engineering Change Notifications (ECNs) for verification, validation, monitoring, inspection methods, procedures and test protocols.
• Evaluate and take part in supplier selection, monitor supplier performance, run supplier quality audits and trend data.
• Review nonconformance records to determine disposition, root cause and corrective/preventive actions, and ensure containment of nonconforming product.
• Maintain the quality management system and assess the manufacturing environment for environmental controls and safety.
• May take part in design and development activities and perform other related duties.

Required profile

• Bachelor's degree in Quality Engineering or a related field, or a Master's degree.
• Strong interpersonal, organizational and communication skills, able to work in a team.
• Preferred: medical device experience or equivalent regulated-industry experience, and experience with deviations, investigations and CAPAs.

Required skills

• Working knowledge of 21 CFR 820, ISO 13485, ISO 14791 and other medical device standards.
• Statistical methods, quality control and tools such as applied statistics, lean manufacturing and Six Sigma.
• Computer skills, preferably spreadsheets, word processing and databases.
• Preferred: SmartCAPA, Oracle and Crystal Reports.