Quality Systems Engineer

Customer Complaints ProgramFacilitate the CC process for ensuring that corrective actions are completed in accordance with relevant ISO requirements (ISO 13485, ISO 14971 & FDA 21 CFR part 820), Jabil Advance Problem Solving methods, and that documentation is complete and compliant with requirements.As a Complaints Coordinator, the Quality Systems Engineer shall facilitate efficient and effective processing customer complaints.Regularly communicate with Engineering, Quality, and manufacturing to implement robust CC within defined timeline.Track and Trend CC metrics including but not limited to weekly and monthly CC metrics.Coordinate with cross-functional team for root cause analysis and corrective & preventive actions.Conduct Verification of Effectiveness for the CCs.Prepare for, participate and drive CC Review Board meetings and get required support from senior management team for CC implementation.Complete harmonization and gap assessment reviews for documents associated to CC process.Facilitate meetings with customer to support closure of open CCs and respond to customer queries.Facilitate investigations on Return Material Authorization requests submitted by customer.Obtain Customer Score Cards for Jabil Healthcare and coordinate with Site Quality and the Work Cell Managers to implement actions if needed.Audit SupportAssists with internal audits, external audits, and FDA inspections.Participates in Second/Third party audits and provides input to Jabil response to any findings.Acts as a member of the review room during audits.Quality Engineering SupportAs required, assists in development of quality plans, work instructions, procedures, harmonization, periodic document reviews, change controls, process change authorizations etc.May perform other quality related duties and responsibilities as assigned.Job Specifications:B.S in a Technical or Applied Science discipline (or equivalent Quality / Process / Project / Automation / Injection Molding experience), with 3-5 years engineering experience.Must have strong verbal and written communication and interpersonal skills.Organizational and planning skills are required to plan, execute, and track quality commitments.Strong problem-solving skills.Ability to multitask and perform efficiently and independently.Knowledge of various quality system methodologies such as 8D, Lean, 5 Why’s, Pareto Analysis, PFMEA, PPAP etc. preferred.Internship / experience in the regulated industry with standards such as cGMP/QSR, ISO 13485 and 21CFR 820 Part 11 preferred.

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