Manager, Global Complaint Handling and Reporting

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

SUMMARY OF DUTIES

ESSENTIAL FUNCTIONS PERFORMED

• Responsible for the following quality management sub-systems:
• * Global Customer Complaint and Evaluation processes
• * Global Adverse Event Reporting process
• * Global Vigilance Reporting process
• Documents, implements, and maintains compliant quality management sub-systems to assure effective operational execution of assigned responsibilities across all Global sites and locations
• Develops, implements, and measures key performance metrics directly associated with effective operational execution of assigned responsibilities.
• Provides Subject Matter Expertise and Training / development requirements and objectives for assigned areas of responsibility, specifically for appropriately evaluating returned medical device products for compliance to stated specifications and ascertaining any respective risks to patient safety.
• Maintains Global Quality Assurance Adverse Event / Vigilance reporting system specifically focused on region specific reporting timeliness and consistent, compliant process execution. Expected to maintain 100% on time Global AE/Vigilance reporting compliance.
• * Global responsibility for evaluation and final determination of all AE/Vigilance reportability decisions.
• Maintains appropriate records for the Global Quality Assurance adverse event reporting system as defined in relevant procedures.
• Establishes and maintains awareness of relevant regulations and standards to ensure the company's post-market surveillance practices align with industry requirements.
• Participates in and, when needed, performs timely trend review of serious and non-serious events and reports to NCAs as appropriate based on statistically significant trends that change the risk to benefit statement of products.
• Works in close collaboration and partnership with cross functional and cross Site Global Quality Assurance stakeholders to optimize overall operational efficiency and effectiveness while maintaining and developing best in class quality systems.
• Supports and assists execution in processes associated with Global Post Market Surveillance including but not limited to the Global PMS Master Schedule, product specific Post Market Surveillance Plans (PMSP), Post Market Surveillance Risk Reviews (PMSRR), Post Market Surveillance Reports (PMSR), Periodic Safety Update Reports (PSUR), Canada Summary Report (CSR), Post Market Surveillance Checklists, Post Market Surveillance trend analysis and reporting.
• May coordinate and interact with various levels of management, international regulatory affairs/quality assurance, and global regulatory bodies on the adverse event reporting, customer complaints and Global PMS requirements and deliverables. Supports timely, responsive, and evidenced based communication to regulatory authorities, notified bodies, customers, and external entities upon request.
• Prepares for, participates in and assists with FDA facility inspections, Notified Body Audits, Post Market Surveillance activities and other governmental inspections as directed.
• Drives continuous improvement initiatives based on post-market surveillance findings, contributing to product enhancements and risk mitigation strategies.
• Performs other 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 quality engineering / engineering / science, nursing or equivalent qualification essential (NFQ Level 7, or higher).

* At least eight (8) years of work-related experience, of which a minimum of five years' experience in a related supervisory, leadership or management role.

* Knowledge of U.S. FDA regulations (21 CFR 803, 806, 820), the Medical Devices Directive (93/42/EEC, as amended), the European Medical Device Regulation 2017/745 (MDR), ISO 13485 Quality System Standards, and Canadian Medical Device Regulation (CMDR), ANVISA, TGA and JPAL/JGMP.

* Direct experience with medical device global adverse event reporting, including but not limited to MDR, MPR, and Vigilance, TGA, etc.

* Knowledge of ISO 14971 Risk Management related activities and requirements.

* Demonstrated experience with electronic data management systems (e.g., Pilgrim, Oracle), computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.

* 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.

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 working background in medical device manufacturing.
• Strongly prefer proven track record leadership experience in the development of a large, international team, in multiple regions.
• Credentialed Clinical professional, Clinician, RN or equivalent education and experience to support regulatory determinations of potential clinical harms and complaint evaluation in support of AE / Vigilance reporting decisions.
• American Society for Quality (ASQ) Certifications - Certified Quality Engineer (CQE) and/or Certified Biomedical Auditor (CBA)
• Regulatory Affairs Certification - RAC (Global).
• Experience with electronic submissions.

COMPETENCIES

• Leadership and coaching.
• Oral and written communication
• Interpersonal skills
• Conflict management
• Problem solving
• Decision making

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 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.