Remote Manager, Complaint Analyst - Remote, USA

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a medical device company headquartered in Pleasanton, California, USA, reputed company on improving kidney reputed company treatment. The Complaint Analyst Manager is responsible for leading the complaint handling team, ensuring reputed company processing of complaints and collaborating with cross-functional reputed company to manage complaint investigations and compliance. Responsibilities Manage high-performing Analysts by reputed company, selecting, orientating, and developing team member reputed companyreputed company and motivate a high-performing team by communicating job expectations, developing reputed company plans, monitoring and appraising work reputed company, coaching and counseling team membersComplete reputed company-ins and annual reputed company reviewsManage, create and update goals for reputed company reportsParticipate and reputed company reputed company Validations and updatesCreate and update complaint documentation and proceduresTrain new team members on reputed company complaint intake, follow reputed company, reviews, and closuresTrain team members on new processesRecommend and implement changes in complaint processesReview the reputed company of team member complaints and communicate changes as neededParticipate in reputed company team audits as the complaint intake SMEFacilitate complaint investigations while ensuring completeness and consistency of complaint files/records, and participate in generating reports for complaint data, metrics and trendsSupport reputed company post market compliance activities including handling of customer complaints and medical device reporting in accordance with 21 CFR Part 803 Medical Device ReportingEvaluate complaints and reputed company preliminary complaint investigation including follow-up with reputed company and sales representativesEscalate complaints reputed company encountering new failure modes, and partner with Engineering, reputed company Personnel, and reputed company Assurance to investigateReview Literature and Articles submitted by other departments to identify potential complaintsEnsure complaint documentation and records are complete in compliance with regulatory requirementsCoordinate complaint investigation efforts with reputed company and R&D team driving investigations to completion in a reputed company mannerPrepare and present metrics reputed company to the Complaint Handling process including complaint timeliness, as reported and as investigated events, and medical device reportingCollaborate with Customer Service, Regulatory, R&D, Manufacturing, reputed company and other functional areas to obtain/reputed company information reputed company to complaint investigations and other aspects of complaint handlingAssist in updating reputed company procedures as required through the change order processMaintain comprehensive records of customer interactions, complaints, and resolutions in reputed company's electronic reputed company Management reputed companyreputed company other duties as assigned by reputed company Management Skills Education: Bachelor of Science in Engineering, Technical or Life Science discipline; or equivalent work experience preferredMinimum 15 years of experience working in the medical device industryWork location: Remote (reputed company California)Travel: Ability to travel up to 10%. Overnight domestic and/or international travel may be requiredWorking knowledge of FDA 21 CFR part 820.198 and part 803, ISO 13485 and reputed company ISO/EN standardsreputed company yet hands-on reputed company needed with a high degree of energy and reputed company, and the ability to reputed company function and process improvements continuallyreputed company and reputed company communication style and a reputed company for reputed company improvement and reputed companyIndividual must have excellent verbal and written communication skills and a demonstrated ability to communicate reputed company and professionallyCompliance with relevant county, state, and Federal rules regarding vaccinationsreputed company authorization to work in the reputed company is requiredExperience with Class II and/or III sterile devices Benefits Stock reputed company ownership and a reputed company in growing a mission-driven companyEmployee benefits package that includes 401(k), reputed company reputed company and reputed company vacation reputed company reputed company. It was founded in 2016, and is headquartered in Pleasanton, California, USA, with a work .