Manager, Quality Engineering

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.
** WORK SHIFT
** DAY (United States of America)
** SUMMARY OF DUTIES
** Responsible for providing management support, direction, and leadership to quality engineers, technicians, Quality Control (QC) personnel (as needed). Provides technical support to ensure product is manufactured to the required regulations, standards, and specifications.
** ESSENTIAL FUNCTIONS PERFORMED
** 1.
Ensures that quality system regulations defined in the Code of Federal Regulations – Quality System 21

CFR Part 820, ISO 13485:2016 and other applicable regulations are followed.  2.
Provides adequate resources to meet department objectives and support operations needs.  3.
Remove barriers which prevent objectives from being achieved and provide managerial and technical support helping others to achieve their assigned tasks.  4.
Provides input to the department budget and manages to that budget.  5.
Resolves problems ensuring that quality needs are being met and manufacturing criteria are adhered to.  6.
Manages Design Transfer Quality Engineers and Technicians in performing design transfer activities, such as process validations, test method validations, and risk management.  7.
Handles miscellaneous problems that arise and resolves problems with product and process quality.  8.
Drives continuous improvement via scrap reduction, waste elimination, variation reduction, etc.  9.
Prepares written reports summarizing the quality status of product and systems and identifies opportunities for improvement.  10.
Collaborates with other Department Managers to ensure business needs are supported and met.  11.
Assists and coordinates the team as required.  12.
Manages department personnel by interviewing, hiring, training, evaluating job performance, disciplining, scheduling work and other related responsibilities.  13.
Reviews risk management files to ensure new risks or risks that have exceeded their thresholds are identified and mitigated.  14.
Performs other related duties, as required.
** ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS*
* • Lifting -- Not to exceed 50 lbs. – local practice may apply.  
• Writing  
• Sitting  
• Standing  
• Bending  
• Visual acuity  
• Color perception  
• Depth perception  
• Reading  
• Field of vision/peripheral
** SUMMARY OF MINIMUM QUALIFICATIONS*
* • Education and/or experience equivalent to a Bachelor’s Degree in Engineering or related field.  
• Eight years of related experience with five of those years in a supervisory capacity.  
• Strong knowledge of design transfer activities, including process validation, statistical techniques, test method validation, and risk management.
• Working knowledge of statistical methodologies, quality control and manufacturing tools such as problem solving, root cause investigation, applied statistics, lean manufacturing, Six Sigma, etc., and project management experience.
** Knowledge of and ability to apply principles of supervision.*
* • Demonstrated interpersonal skills and the ability to delegate work.  
• Attention to detail and good organizational skills.  
• Problem solving and conflict management skills.  
• Working knowledge of United States and international standards as applicable to the department.  
• Demonstrated computer skills preferably spreadsheets, word processing, database (Oracle preferred), statistical analysis and other applicable software programs.
** COMPETENCIES*
* • Critical thinking  a)    Problem solving  b)    Lean / Six Sigma  c)    Trend analysis  
• Data interpretation  a)    Budget management  b)    Work/Project management  
• Quality toolkit  a)    Quality control principles - inspection / sampling plans  b)    Corrective and preventive action  c)    Change Control management.  d)    Complaint investigation  
• Leadership and empowerment  a)    Staff training/development  
• Interpersonal skills  a)    Supervisory process
** COMMENTS
* * Infectious Control Risk Category III:

The…