Quality Systems Analyst

Clinton, MA, United States

JOB SUMMARY

The Quality Systems Analyst (QSA) is responsible for ensuring the Quality Management System meets or exceeds customer quality and applicable regulatory requirements for products and services. The role breaks into 2 main aspects. QMS system alignment and QMS system performance.

The analyst is responsible for maintaining QMS procedures through regular reviews which ensure they fulfill the requirements of ISO and Jabil’s business processes. Secondly, the effectiveness of the QMS must be measured objectively through analysis of facts and data. The analyst will use site and system data to produce trend reports which identify systemic issues requiring site corrective or preventative actions. This data will support the Management Review process and the ongoing identification of risk mitigation and continual improvement opportunities.

The analyst will hold SME status for Quality and Manufacturing systems including JOS and CAPA and should possess a strong analytical background and proficiency in statistical tools. The analyst will provide input to future developments in shop floor and quality system tools.

ESSENTIAL DUTIES AND RESPONSIBILITIES

· Analysis of site QMS data to support bi-annual Mgt Review process.

· Perform trend analysis on key quality metrics including FPY, DPM, OTD, CRR

· Identify systemic QMS issues, risks & negative trends (WC/Site)

· Perform Root Cause Analysis & drive Corrective and Preventative Actions

· Identify positive trends & best practices. Manage a Best Practice database to ensure proliferation

· Audit and administer CAPA and Audit Mgt processes - Pilgrim SmartSolve SME

· Establish correlation between QMS performance & outgoing quality trends/Customer Sat

· Provide input and other related support to the Mgt Review process

· Use statistical tools (Mini-tab) to identify negative trends and continuous improvement opportunities

· Maintain QMS procedures ensuring alignment with ISO9001 & business requirements

· Communication of Quality Alerts

· Interface with Business Systems Group on next generation JOS applications

· Ability to investigate and analyze technical and regulatory issues (site)

· Track waiver requests and identify areas for QMS document improvements to prevent waiver usage

· Identify quality system issues and recommend / implement corrective and preventative actions.

· Act in the capacity of an internal auditor for the Quality Management System

· Ability to process CA or PA from audit findings and track issues to closure

· Track progress of follow-up items from TUV & Internal audit reports, Mgt Review, Corrective/Preventive Action Requests (8D) and other continuous improvement projects

· Support and/or coordinate process improvement projects and assure coordination with other functions as well as compliance with regulatory, customer and company quality requirements

Critical focus areas:

· QMS system documentation and alignment with requirements

· QMS system effectiveness and correlation with quality performance

· Trend analysis of site QMS data including Internal Audits, CAPA & Mgt Review

· Analysis of key Quality, Operations and other Business Metrics (site trends)

· Identification of business or operational risks and/or best practices

· Identification of Preventative Actions – site

· CAPA Pilgrim SmartSolve (CAPA & Audit)

· Input and support to Management Review

· Support for ISO Certification program

· Perform on-site Internal Audits against QMS procedures & ISO requirements

· Open communication with sites focusing on preventive actions and activities

· Liaison with regional and sector Operations Development Teams`

· Maintain Quality 1st mentality within the organization

· May perform other duties and responsibilities as assigned.

JOB QUALIFICATIONS

KNOWLEDGE REQUIREMENTS

· Expertise in quality systems & shop floor tools including MES, JOS & CAPA

· Familiar with QRQC, LPA and problem solving tools

· Internal Auditor ISO9001 with experience in at least one other std (ISO13485, TS16949, AS9100, TL9000)

· In-depth knowledge of Jabil’s QMS system

· Strong analytical skills that include trending and evaluation of data with the ability to identify potential process problems, risks and opportunities for improvement.

· Excellent computer skills including experience with Word Processing and Database applications. MS Office and statistical

software expertise essential.

· Excellent report and presentation preparation skills utilizing MS office or similar tools

· Ability to analyze data, drive root cause using analytical and/or statistical tools

· Ability to correlate QMS performance with product and process quality trends

· Desire to continually improve the efficiency and effectiveness of the QMS

· Understanding of quality system regulatory requirements and how they relate to the business

· Organized self-starter and pro-active approach combined with excellent time-management skills

· Ability to periodically attend conference calls or symposiums outside normal working hours.

· Results oriented, with the ability to interact with technical and non-technical personnel

· Strong team player with the ability to communicate at all levels, horizontally and vertically, throughout Jabil

· Advanced PC skills, including training and knowledge of Jabil’s software packages.

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