100 Merit Medical Systems, Inc. - South Jordan, UT
posted 2 months ago
Full-time - Mid Level
South Jordan, UT
5,001-10,000 employees
About the position
The Quality Engineer 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, all aimed at optimizing quality systems and documentation to improve patient outcomes.
Responsibilities
- Conducts complete and conceptually related studies to approach technical problems.
- Performs technical work where available guides and precedents contain critical gaps.
- Contributes techniques to solve specific problems and drive continuous improvement.
- Keeps abreast of new scientific methods, standards, regulations, and developments affecting the organization.
- Plans, organizes, mentors, and supervises the work of engineers or technicians on various projects.
- Coordinates risk analysis/management activities and leads risk management analysis meetings.
- 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 to maintain the effectiveness of the quality management system.
- Evaluates the work environment to ensure it is adequately controlled and monitored.
- May participate in design and development activities.
- Supports 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.
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
