Senior Quality Assurance Engineer I

Merit Medical Systems - South Jordan, UT

Full-time - Senior

Onsite - South Jordan, UT

Merchant Wholesalers, Durable Goods

About the position

The Senior Quality Assurance Engineer I at Merit Medical is responsible for providing extensive quality engineering support for medical devices and processes. This role involves mentoring quality assurance employees, conducting failure investigations, and ensuring compliance with quality standards. The engineer will also be involved in risk analysis, quality inspection planning, and addressing supplier quality issues to optimize quality systems and documentation.

Responsibilities

• Conducts complete and conceptually related studies to approach technical problems.
• Performs technical work where available guides and precedents contain critical gaps.
• Contributes techniques which are of material significance to solve specific problems and drive continuous improvement.
• Keeps abreast of new scientific methods, standards, regulations, and developments affecting the organization.
• May plan, organize, mentor, and supervise the work of engineers or technicians.
• Responsible for coordinating risk analysis/management activities.
• Reviews, approves and generates Engineering Change Notifications (ECNs).
• Mentors and evaluates competency of Quality Auditors, Quality Engineers, and technicians.
• Evaluates and participates in the selection of suppliers by monitoring supplier performance.
• Reviews nonconformance records to determine disposition, root cause and need for corrective actions.
• Ensures containment of nonconforming product has been performed.
• Identifies and implements changes necessary to maintain the quality management system.
• Evaluates the work environment in which product is manufactured.
• May participate in design and development activities.
• May support Internal Audit and supplier audit activities.
• Performs other related duties and tasks as required.

Requirements

• Bachelor's Degree in Engineering or related field with six years of quality engineering experience.
• Strong interpersonal, organizational, and communication skills.
• Demonstrated working 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.
• Knowledge of applicable regulatory agency regulations.
• Demonstrated computer skills in spreadsheets, word processing, and databases.

Nice-to-haves

• Medical device experience or equivalent experience in a regulated industry.
• Experience handling deviations, investigations and CAPAs.
• Experience with MasterControl, SmartCAPA, Oracle and Crystal.
• PMA (Premarket Approval) experience.

Benefits

• 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