Quality Assurance Engineer III (Sensors)

Why Merit?

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

Develops, interprets, and implements quality policies, manages quality systems, and facilitates compliance at the respective site and/or region.

Assigned site Quality System Management Representative; responsible for providing support to ensure product is manufactured to the required regulations, standards and specifications; primary customer contact on all quality related queries e.g. compliance audits & follow up, customer complaints, quality agreements, and technical agreements.

Works in close collaboration and partnership with Global Quality Assurance Team, other divisions, departments and functions, to optimize overall operational efficiency and effectiveness while maintaining & developing best in class quality systems.

ESSENTIAL FUNCTIONS PERFORMED

1.Takes ultimate responsibility for the direction and effective management of assigned departments within the quality assurance function, ensuring that each department is resourced, structured and managed to support the goals of the organization.  Departments may include, but not limited to:

•Calibration

•CAPA

•Compliance

•Document & Data Control

•Design Assurance

•Environmental Control

•Field Assurance

•Risk Management

•Internal / External Quality Audit

•Quality Control, Product Release

•Management Review

•Quality Inspections

•Quality Engineering

•Real Time Aging

•Supplier Quality

•Validation (Product & Process)

2.May be assigned Quality System Management Responsibilities for Merit Medical Systems Inc at the site and/or region; may be primary regulatory agency and customer contact on all quality related queries for the site e.g. compliance audits & follow up, customer complaints, quality agreements, and technical agreements.

3.Provides input regarding Quality Assurance Program strategy for the site and/or region and meets the required regulations applicable to the processes managed, products produced, and global markets.

4.Key member of the Management Team that manages, develops and drives Merit Sensor Systems Inc. to deliver the goals of the business i.e. Best In Class (Safety, Quality, Business Processes), Revenue Growth & New Business Development.

5.Promote, support the “Merit Business Excellence System” Program; lead by example; partner with functional leaders to ensure that this program, the organizations objectives and values are at the forefront of decision making and action.

6.Identifies opportunities to improve organizational systems and processes to save costs, improve efficiency, maintain compliance, increase the value of products, or increase customer satisfaction.

7.Develops capital plans and budgets for the Quality Assurance Department.

8.Provides Merit Sensor Systems Inc. with recommendations and decisions which uphold company in furnishing quality products to the customer by:

• Developing and directing annual ‘Quality Assurance” team goals to deliver the key company objectives and continuous growth of division.

• Reviewing performance of Quality Assurance division in achieving compliance and system improvement objectives.

• Preparing or reviewing written procedures and documentation for testing and manufacturing processes.

• Tracking information about customer complaints to provide design, development and operations teams with product quality information.

• Providing recommendations and decisions regarding the disposition of non-conforming products; stops production lines if problems with quality arise and initiates preventive and corrective actions to ensure non-recurrence.

• Coordinating Emergency Management Team (EMT) meetings and participates/manages product investigations.

9. Provides technical support for the manufacture of existing products and the growth and development of new products / technologies.

10. Partner with Research and Development (Product & Technology) function ensuring:

• Customer requirements are met

• Safe and effective product design

• Compliance with design control requirement

• Design for manufacture

• Quality at source

• Smooth transition of new products and Technologies to operations groups

11. Participate, support and provide independent review of all verification and validation activities.

12. Functional manager for quality department:

• Coordinate assigned work ensuring appropriate corrective action for sub-optimal performance, and recognition of strong performance creating avenues for advancement.

• Manage training and career developmental needs.

13. Perform other related tasks as required. 

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

•    Lifting -- Not to exceed 50 lbs. – local practice may apply.
•    Writing
•    Sitting
•    Standing
•    Bending
•    Vision
•    Color perception
•    Depth perception
•    Reading
•    Field of vision/peripheral
•    Fine motor skills
•    Noise
•    Chemical vapors

SUMMARY OF MINIMUM QUALIFICATIONS

• Education and/or experience equivalent to a Bachelor’s Degree in Quality Engineering/Engineering/ Science, or equivalent qualification essential (NFQ Level 7, or higher).

• At least five years of work-related experience, of which a minimum of one year experience in a related management role. 

• Proven track record in leading organizations through external inspections / audits (e.g. Notified Bodies, Competent Authorities, and Customers).

• Working knowledge of and experience with ISO 9001 Quality System Standard, ISO 14001 (Environmental), ISO 45001 (Health and Safety) and ISO 50001 (Energy Management).

• General knowledge of the Semiconductor or Micro Electromechanical Systems (MEMS) industry and the applications that pertain to  the automotive, industrial, and medical fields.

• PC skills including standard offices packages as well as ability to understand and learn customized computer software programs such as spreadsheets, word processing, database (Oracle preferred), and statistical analysis (JMP, Minitab, or similar).

• Excellent communications skills to include oral and written fluency in English and local language as deemed appropriate.  

PREFERRED QUALIFICATIONS

• Demonstrated aptitude for process improvement and use of Lean and Six-Sigma resources and tools.

• Strongly prefer Semiconductor or MEMS device manufacturing management experience.

• Strongly prefer proven track record leadership experience in the development of a large, international team, in multiple regions.  

COMPETENCIES

• Demonstrated leadership skills including the ability to coach, assess, evaluate, develop, motivate and empower others.

• Excellent communication (oral and written) and interpersonal skills with the ability to convey information and ideas in a variety of media, tactful, confident at all levels, internal and external. 

• Excellent data, analysis, trends, and reporting skills.  Ability to read and interpret documents.  Ability to write clearly and informatively technical documentation, routine reports, correspondence, procedures and work flows.  Presents numerical data effectively.  Attention to detail without losing site of the big picture.

• Identifies and resolves problems in a timely manner; develops alternative solutions; works well in a group problem solving situations; presents ideas and information in a manner that gets others' attention; displays willingness to make decisions; exhibits sound and accurate judgment; supports and explains reasoning for decisions includes appropriate people in decision-making process.  

• Strong project management skills, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation. 

• Demonstrates organizational values in carrying out of all assigned responsibilities/tasks.  

COMMENTS

Infectious Control Risk Category II:

The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs.  Risk category II states employment and procedures that may require exposure.

As an eligible Merit employee, you can expect the following:

* 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

To see more on our culture, go to www.merit.com/careers.

Military Veterans are encouraged to Apply.

Merit is a proud Utah Patriot Partner committed to hiring our Veterans.