Remote, IND
1 day ago
Customer Quality Specialist
**Position Summary** This position is responsible for enhancing customer satisfaction for all customers of Advanced Sterilization Products. The responsibilities include support of the global complaint handling process through timely evaluation, investigation and closure of product complaints in accordance with established company procedures and worldwide regulations and standards. The role requires completion of complaint investigations and escalation of trends and product problems. **Duties and Responsibilities** Under general direction and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position: + Reviews Incoming Complaints and Completes Good-Faith Effort to Collect Additional Information as Required + Authors Clear, Technical, and Accurate Reports Describing Complaints and Investigations for Compliance Files Independently Completes Low Complexity Complaint Investigations within Required Timelines + Coordinates Initiation of Company Issue Escalation Process as Required + Participates in Improvement Initiatives + Maintains Compliance to Applicable Foreign and Domestic Regulations Governing the Management and Processing of Medical Device Related Complaints including Protected Health Information (PHI) and Patient Privacy Laws + Responsible for communicating business related issues or opportunities to next management level + Performs other duties assigned as needed **Education** Bachelor’s degree is preferred **Years of Related Experience** Prefer 2 years’ experience in the Medical Device industry. **Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations** + Critical thinking and investigation skills are required. + Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required. Employee must be able to effectively prioritize and manage multiple activities and responsibilities. + Ability to understand and follow complex written procedures is required. Candidates should be familiar with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices. + Ability to function in a team environment and deliver on team objectives is required. Ability to influence and drive change is preferred. Prefer project management and/or process mapping experience. + Strong written and verbal communication skills are required. Must be highly proficient in reading, writing, and speaking the English language. Prefer developed presentation skills. + Professional demeanor on the phone and in email is required. Technical writing is a routine part of this position. Strong attention to detail is required. + Familiarity with computers and Windows-based PC applications. Ability to learn and manipulate complex computer system applications is required. Ability to type at least 50 words per minute (WPM) is required. Experience with word processor software (e.g. Microsoft Word) and internet browsers (e.g. Internet Explorer) is required. Prefer experience with Complaint Management Systems. + Normally receives no instructions on routine work, but all work is reviewed and approved. Receives general instruction on new tasks. Detailed initial training on procedures and software is provided. + Prefer prior medical device complaint handling experience, or knowledge of medical device regulations. + Prefer working knowledge of sterilization and/or high-level disinfection technologies. **Fortive Corporation Overview** Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions. We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions. We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact. At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference. At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone. Fortive: For you, for us, for growth. This position is also eligible for bonus as part of the total compensation package. We are an Equal Opportunity Employer Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@fortive.com.
Confirm your E-mail: Send Email