Quality Compliance Specialist

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 supports quality compliance systems and objectives for Global QA; maintains a quality mindset and assists continuous improvement efforts and quality system initiatives to industry requirements.

This position will interact with internal cross functional groups as well as external customers.

ESSENTIAL FUNCTIONS

PERFORMED

1. Answers and resolves customer inquiries regarding systems and product inquiries; refers higher level issues to manager.
2. Assures that uncovered customer concerns, needs, and problems are properly communicated within the organization for timely resolution.
3. Prepares written correspondence to address customer inquiries and/or concerns.
4. Develops reports and conducts compilation of information for customers, department and company management.
5. Proactively and continuously improves internal systems and processes with a quality mindset.
6. Under lead auditor direction, participates in internal audits of Merit’s quality system, including audit planning, execution, and audit follow up activities.
7. Understands and adheres to current Quality System Regulations.
8. Assists with updating/developing new systems and procedures to streamline business processes.
9. Performs other related duties and tasks as required. SUMMARY OF MINIMUM QUALIFICATIONS

• Education equivalent to a High School diploma and eight years of related experience or bachelor’s degree in a scientific/engineering discipline.
• Excellent interpersonal skills and the ability to resolve customer problems efficiently and effectively.
• Demonstrated computer skills, preferably spreadsheet, word processing, database, and other applicable software programs.
• Good organizational skills and the 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.
• Ability to manage multiple tasks and project 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.

PREFERRED QUALIFICATIONS

• Medical device industry knowledge strongly preferred
• Certified Quality Auditor or Certified Quality Engineer by ASQ
• Technical writing skills COMPETENCIES
• Customer Service
• Troubleshooting/negotiation
• Demonstrated working knowledge of 21 CFR 820, ISO 13485, ISO 14971, and other medical device related standards, preferred
• Interpersonal/written/verbal communication skills
• Computer skill s ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
• Lifting – Not to exceed 50 lbs. – local practice may apply.
• Writing
• Sitting
• Standing
• Vision; computer screen
• Reading 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.