Program Manager, Quality Systems

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

This position manages and is responsible for managing the VIP program at Merit. This includes but is not limited to timely completion of projects that meet or exceeds its performance goals. Provides compliance guidance and quality operational support for manufacturing or distribution operations, services, and systems. Collaborates with Quality management to recommend, design and implement functional process improvements. Develops, establishes, and maintains quality methodologies, systems, and practices that meet company, customer, and regulatory requirements. This position will interact with and mentor internal cross functional groups as well as external customers.

ESSENTIAL FUNCTIONS PERFORMED

1. Manages VIP Program for Merit Medical and multiple core business improvement projects to assure timely delivery of new or improved processes which meet user needs.

2. Creates, tracks, and meets project schedules, plans, and budgets across multiple Merit sites.

3. May act as project leader or oversee project leader activities.

4. Monitors work performed by assigned department staff and assists staff in working on team projects.

5. Proactively and continuously improves internal systems and processes with a quality mindset.

6. Acts as a subject matter expert (SME) and supports operational quality issues for manufacturing or distribution sites as applicable.

7. Develops reports and conducts compilation of information for site and functional management.

8. Collaborates with cross-functional colleagues regarding the impacts of enhancements and process changes.

9. Understands and adheres to current Quality System Regulations and all applicable regional regulations.

10. Supports document updates and reviews. Communicates impact and drives resolutions with the stakeholders.

11. Understands, interprets, and applies documentation control principles and processes to ensure compliance with the global quality system.

12. Performs other related duties and 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

SUMMARY OF MINIMUM QUALIFICATIONS

• Education and/or experience equivalent to a bachelor's degree in a scientific/engineering discipline.
• Eight (8) years of job relevant experience.
• Demonstrated computer skills, preferably spreadsheet, word processing, database, and other applicable software programs.
• Ability to manage multiple tasks and projects simultaneously, and to prioritize work, goals and tasks per Global QA objectives.
• Demonstrated ability to independently function in a fast-paced environment while moving multiple simultaneous projects forward.
• Demonstrated working knowledge of 21 CFR 820, ISO 13485, and other medical device related standards.

PREFERRED QUALIFICATIONS

• Medical device industry knowledge strongly preferred.
• Certified Quality Auditor or Certified Quality Engineer by ASQ.
• Technical writing skills.

COMPETENCIES

• Excellent interpersonal skills.
• Ability to resolve customer problems efficiently and effectively.
• Good organizational skills.
• Ability to work under strict time constraints to meet customer requirements.
• Strong oral and written communication skills.
• Excellent attention to detail and time management skills.
• Ability to work independently and with cross-functional teams.
• Customer Service skills.
• Troubleshooting/negotiation skills.

COMMENTS

Infectious Control Risk Category III:

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 III states employment and procedures that do not 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.