Complaint Specialist

We are looking for a Complaint Specialist to join our team and experience what being "The Best Virtual Care Solution" means.

Some of the perks that our employees enjoy include:

• Growth possibilities
• Competitive Health & Welfare Benefits
• Company paid Basic Life insurance: $50,000 for each employee
• Company paid Long-Term Disability benefits
• 401k plan with company match
• Employee Appreciation Days
• Employee Wellness Events
• Competitive pay

Other benefit offering includes:

• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Job Summary:

Duties & Responsibilities:

• Reviewing and processing feedback and complaints for evaluation as required by applicable regulations, standards, and GlobalMed procedures.
• Responsible for communication, coordination and collaboration with staff, department managers, and the management representative as it relates to their areas of responsibility.
• Communicates adverse events/reportable incidents to the Director of Quality and Regulatory Compliance.
• Conducts review of QC data and Non-Conformance reports.
• Conducts review of Device History Records (DHR) in support of created complaint items.
• Obtains detailed information to support complaint investigations.
• Leads complaint investigations and root cause analysis.
• Responsible for performing data analysis to ensure feedback and complaint work items are processed in accordance with applicable procedures.
• The ability to understand and follow QMS Procedures. (e.g., SOP and Test Methods.) 
• Experience with computer-based applications (MS Word, MS Excel, NetSuite). 
• Provide training for personnel involved in complaint handling as directed by management.
• Support internal/external audits as needed.
• Perform other duties and responsibilities as assigned.

Qualifications:

• Bachelor's Degree in relevant field or equivalent work experience.
• Minimum of 5 years of relevant experience in complaint handling, post market surveillance, quality assurance, or regulatory in medical device or pharmaceutical industry.

Skills & Competencies:  

• Knowledge of global regulations for medical device reporting and complaint handling.
• Working knowledge and application of ISO 13485 and FDA 21 CFR Part 803 & 820 quality system requirements and other applicable regulations.
• Strong communication skills, both verbal and written.
•  Experience with computer-based applications (MS Word, MS Excel, ERP systems). 
• The ability to understand and follow QMS Procedures. 
• CAPA and complaint handling experience required.
• Working knowledge and application of Root Cause Analysis (RCA) Tools.
• Excellent time management and multitasking skills
• Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
• Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
• Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
• Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
• Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
• Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.

Physical Demands & Work Environment: 

• Ability to work at least 40 per week.
• Ability to utilize keyboard, mouse, and computer for up to 8 hours per day.
• Ability to utilize telephone for approximately 4 hours per day.
• Ability to lift and/or move at least 10 pounds.
• Ability to perform simple grasping, including handwriting, paper manipulation, sorting, folding, etc. periodically throughout the entire workday.
• Occasionally remain in a stationary position throughout the day. 
• Occasionally work around fumes, airborne particles or chemicals. 

GlobalMed is an equal opportunity employer. We are committed to providing a workplace that is free from discrimination of any kind and to promoting an environment that fosters inclusion, diversity, and mutual respect among our employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected status under applicable law. GlobalMed is dedicated to ensuring the fulfillment of this policy with respect to hiring, placement, promotion, transfer, demotion, layoff, termination, recruitment, compensation, and any other terms and conditions of employment. We actively seek diversity in our workplace and encourage candidates from all backgrounds to apply. Reasonable accommodations will be made for qualified individuals with disabilities.