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Customer Quality Specialist

4 weeks ago

Delhi, Delhi, India Advanced Sterilization Products Full time

This position supports remote work. We have offices in Bangalore, Mumbai and Chennai in India.Position SummaryThis 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 ResponsibilitiesReviews Incoming Complaints and Completes Good-Faith Effort to Collect Additional Information as RequiredAuthors Clear, Technical, and Accurate Reports Describing Complaints and Investigations for Compliance Files Independently Completes Low Complexity Complaint Investigations within Required TimelinesCoordinates Initiation of Company Issue Escalation Process as RequiredParticipates in Improvement InitiativesMaintains 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 LawsResponsible for communicating business related issues or opportunities to next management levelPerforms other duties assigned as neededEducationBachelor's degree is preferredYears of Related ExperiencePrefer 2 years' experience in the Medical Device industry.Knowledge, Skills, Abilities, Certifications/Licenses, and AffiliationsCritical 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.