Job Information
AMERICAN CYBER SYSTEMS INC Manager, Global Complaint Management in SALT LAKE CITY, Utah
Position Summary
This position manages operations for ICU Medical's Global Complaint Management day-to-day activities and workload of direct reports and contractors to ensure timely and accurate processing of records. Collaborates with other business partners to ensure compliance to applicable procedures and regulations for marketed products.
Essential Duties & Responsibilities
• Manages daily operations of both the Global Complaint Management device teams and outsourced contractors ensuring timely and accurate registration, follow up, and processing of complaints.
• Ensure the right individuals are tasked with the appropriate responsibilities.
• Allocates tasks and direction to team based on overall workload; manages team's work schedules and monitors metrics to ensure commitments are being met.
• Collects, analyzes, and summarizes key performance metrics and drives process improvements.
• Serve as a starting point for issue escalation by direct reports or contractors.
• Responsible for identifying issues that may jeopardize the outsourced vendor relationship, and escalate appropriately.
• Responsible for building and maintaining a positive and collaborative working relationship between ICU Medical and the outsourced v endor.
• Evaluates employee performance, provides feedback, coaching, and development.
• Responsible for resource allocation and ensuring adequate staff.
• Supports and facilitates global audits/inspections, including developing strategies for audit preparation, execution, and interfacing with senior/ site leaders during inspections, audits, investigations, as needed.
• Responsible for implementing Business Continuity Plan when necessary or as directed by GCM Sr. Manager.
• Establishes and maintains training requirements for direct reports and contractors. Establishes development plans for applicable direct reports.
• Actively engages with internal and external customers during complex/difficult situations working collaboratively to resolve or identify appropriate actions. Assists Customer Advocates as requested.
• Responsible for identifying and im plementing corrective actions as required.
• Work on special projects as they arise.
Knowledge, Skills & Qualifications
• Utilize working knowledge/experience with medical devices and key global regional complaint/adverse event regulatory requirements
• Accountable for decisions and actions of the team. Makes sound decisions on complex issues.
• Coach, influence, develop, and nurture a cohesive team to promote a productive and positive environment
• Work effectively and efficiently in a cross-functional environment with medical, engineering, risk management, and regulatory professionals
• Analyze, prioritize, delegate and meet critical deadlines. Ensure appropriate responsibilities are assigned to the appropriate level of employee.
• Present and communicate effectively to all levels of the organization and customers
• Proficient with computers and software such as Outlook, Word, Excel, PowerPoint, WebEx, TrackWise Digital
• Address and resolve con flict directly and constructively focusing on issues and behaviors.
• Experience in employee recruiting and hiring activities, employee performance reviews, developing goals and development plans.
Education and Experience
• Must be at least 18 years of age
• Bachelor of Science Degree in Nursing, Bio-Medical Engineering, Pharmacy, Medical Technology/ Clinical Laboratory Science, or other scient ific field.
• Minimum 5 years' Quality or Regulatory Affairs experience within the Medical Devices Manufacturing industry.
• Minimum 2 years leadership/supervisory/management experience with demonstrated ability to lead medical device post-market surveillance cross-functional teams.
Physical Requirements and Work Environment
• This is largely a sedentary role.
• This job operates in a professional office env ronment and routinely uses standard office equipment.
• Typically requires travel 5-10% of the time
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.