Director, Design Assurance - South Jordan, UT

Job Description

SUMMARY OF DUTIES*

Develops, interprets, and implements quality policies, manages quality systems, and facilitates compliance at the respective site(s), regions or globally relating to new product development and design transfer post successful launch. Works in close collaboration and partners with Site Global Quality Assurance Team, other divisions, departments, and functions, to revise Quality Management System as required by introduction of new products and/or by regulation. Keeps abreast of new scientific methods and developments affecting the organization for the purpose of recommending changes as warranted by such developments.

ESSENTIAL FUNCTIONS PERFORMED

1. Takes ultimate responsibility for the direction and effective management of Design Assurance, ensuring that department is resourced, structured, and managed to support the goals of the organization. May have functional responsibility and oversight for design assurance at other divisions.
2. Develops capital plans and budgets for the Design Assurance Department.
3. Assigned primary regulatory agency and customer contact on all quality related queries relating to design control/design transfer e.g., compliance audits follow up, customer complaints, quality agreements, and technical agreements.
4. Instrumental in setting strategy to enhance and maintain Merit Medical Systems Inc. Global Design Assurance Program, to meet the required regulations applicable to the processes managed, products produced, and global markets served e.g., US, South America, Canada, EMEA, APAC, CSR (Customer Specific Requirements).
5. Identifies opportunities to improve organizational systems and processes to save costs, improve efficiency, maintain compliance, increase the value of products, or increase customer satisfaction.
6. Provides Merit Medical Systems Inc. with recommendations and decisions which uphold company and regulatory standards in furnishing quality products to the customer by:
   
   1. Developing and directing annual 'Design Assurance' team goals to deliver the key company objectives and continuous growth of personnel.
   2. Preparing or reviewing written procedures and documentation for Quality System Processes, Testing and Manufacturing processes relevant to scope of responsibilities.
   3. Leading Design Reviews as prescribed within the Quality Management System, gate keeper to progress each phase through to Executive Reviews.
   4. Tracking information about customer complaints to provide design development teams with product quality information.
   5. Providing recommendations and decisions regarding the disposition of non-conforming products; determines when Regulatory/Clinical approval is required; stops production lines and/or product shipments if problems with quality arise and initiates preventive and corrective actions to ensure non-recurrence.
   6. Coordinating Emergency Management Team (EMT) meetings and participates/manages product investigations.
7. Provides technical support for the manufacture of existing products and the growth and development / transfer of new products / technologies.
8. Partner with Research and Development (Product Technology) function ensuring:
   
   1. Customer requirements are met
   2. Safe and effective product design
   3. Compliance with design control requirements
   4. Design for manufacturability
   5. Quality at source
   6. Smooth transition of new products and Technologies to operations groups
9. Participate, support, and provide independent review of all verification and validation activities.
10. Functional manager for a team of design assurance personnel:
    
    1. Resource functional areas, projects with the required resources.
    2. Select, coordinate assigned work, mentor, manage performance for all team members ensuring appropriate corrective action for sub-optimal performance, and recognition of strong performance creating avenues for advancement.
    3. Manage training and career developmental needs of team to the benefit of the individuals and the organization, ensuring that talent is positioned and utilized for maximum effectiveness.
11. Deputise as for Vice President, Global Quality Assurance as directed.
12. Perform other tasks 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
• Fine motor skills

SUMMARY OF MINIMUM QUALIFICATIONS

• Education and/or experience equivalent to a Bachelor's Degree in Quality Engineering/Engineering/ Science/Materials Science/Biomedical Engineering or equivalent qualification essential (NFQ Level 7, or higher).
• At least ten years of work-related experience, of which a minimum of four years' experience commensurate with responsibilities outlined above.
• Proven track record in leading organizations through external inspections / audits (e.g., FDA, Notified Bodies, Competent Authorities, and Customers).
• Working knowledge of and experience with U.S. FDA regulations, the Medical Devices Directive (93/42/EEC), Medical Device Regulation MDR EU 2017/745, ISO 13485 Quality System Standard, Medical Device Single Audit Program ISO 14971 Risk Management, Canadian Medical Device Regulation (CMDR), ANVISA and JPAL/JGMP.
• General knowledge of the medical device industry and the applications of Merit's products in the medical field.
• PC skills including standard offices packages as well as the ability to understand and learn customized computer software programs.

PREFERRED QUALIFICATIONS

• Post graduate diploma/Master's degree in Quality Management.
• Demonstrated aptitude for process improvement and use of Lean and Six-Sigma resources and tools.
• Strongly prefer medical device design and manufacturing management experience, within global medical device markets.
• Strongly prefer proven track record leadership experience in the development of a large, international team, in multiple regions.

COMPETENCIES / EXPECTATIONS

• Strong leadership ability, and the ability to influence at all levels within the organization.
• Demonstrated leadership skills and the ability to coach, assess, evaluate, develop, motivate and empower others.
• Ability to provide functional, cross functional and organizational leadership as required by the demands of the role.
• 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 workflows. 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 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 the 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

Merit Medical Systems, Inc., an Equal Opportunity Employer M/F/D/V, is a dynamic, progressive and innovative company with a strong global presence. Our culture is highly energetic, family friendly, values its employees, and promotes them as standard business practice. To see what it is like to work at Merit take a look at our new recruiting video on YouTube at www.youtube.com/meritmedical to see the video titled "Great people, Great products, Great Company". Merit currently has the above opening located in South Jordan, Utah. Excellent compensation and benefits packages will be offered to the right candidate.

COMPANY HISTORY Merit Medical Systems, Inc. (NASDAQ, MMSI) was founded in 1987 by Fred P. Lampropoulos. Merit develops, manufactures and markets single-use medical devices primarily for diagnosing and treating cardiovascular and vascular disease. Merit has been successful in introducing and marketing innovative, high-quality products through its expertise in new product design and its capabilities in injection and insert molding of plastics; the application of its proprietary electronic and sensor-based technologies; and wire, extrusion and catheter technologies. Merit also develops and markets embolotherapeutic products for the treatment of uterine fibroids, hypervascularized tumors, and arteriovenous malformations. Embolotherapy procedures are primarily performed by interventional radiologists and use bioengineered microspheres to create targeted vascular occlusion and drug delivery. The Company is utilizing its competitive advantages and technologies to develop and offer products that address a wide range of needs related to cardiology and radiology procedures performed in hospitals. Sales are made primarily to U.S. hospitals through a direct sales force. The Company markets its products in over 60 countries worldwide, utilizing a direct sales force in Europe, and distributors for the remainder of the world.

MERIT MEDICAL SYSTEMS, INC.

www.merit.com/careers

EQUAL OPPORTUNITY EMPLOYER M/F/D/V

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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.

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.

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Military Veterans are encouraged to Apply.

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